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To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

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ClinicalTrials.gov Identifier: NCT03544281
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

This study will evaluate the safety and tolerability profile of GSK2857916 when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Arm A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study is a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of GSK2857916 in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of GSK2857916 at selected dose levels and dosing schedules in combination with Len/Dex or Bor/Dex.

Up to a total of 123 evaluable participants will be enrolled in the study with up to 33 Part 1 and up to 90 in Part 2. Participants receiving treatment Arm A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, or death. The participants receiving treatment Arm B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with GSK2857916, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, or death.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: GSK2857916 Drug: Lenalidomide Drug: Dexamethasone Drug: Bortezomib Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

This is a 2-part study. Part 1 of the study is a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of GSK2857916 in combination with two SoC regimens (Arm A - GSK2857916 with Len/Dex and Arm B - GSK2857916 with Bor/Dex) For Arm A (GSK2857916 with Len/Dex), Part 2 of the study will further evaluate the safety and preliminary clinical activity of up to 3 dose levels and up to 2 dosing schedules of GSK2857916 with Len/Dex .

For Arm B (GSK2857916 with Bor/Dex), Part 2 of the study will further evaluate the safety and preliminary clinical activity of up to 2 dose levels and up to 2 dosing schedules of GSK2857916 with Bor/Dex.

Masking: None (Open Label)
Masking Description: This is an open-label study; therefore, no blinding of treatment identity will be done for both treatments.
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : January 3, 2023
Estimated Study Completion Date : January 3, 2023


Arm Intervention/treatment
Experimental: Arm A, Part 1, GSK2857916 plus lenalidomide plus dexamethasone
Modified Toxicity Probability Interval (mTPI) design will be used to guide Part 1 dose escalation. Up to 3 dose levels of GSK2857916 (1.9 milligram/kilogram (mg/kg), 2.5 mg/kg; 3.4 mg/kg) and 2 alternate dosing schedules will be evaluated in combination with a fixed dose of Len/Dex. Based on data from Arm A, first dose investigated in Amendment 2 will be 1.9 mg/kg. Cohorts will be recruited in blocks of 3 participants and will enroll with at least 1 day between each participant's first dose of GSK2857916 to reduce risk of exceeding the maximum tolerated dose (MTD). For a move to the next dose level, dose-limiting toxicities (DLTs)- from 3 evaluable participants will be reviewed. Participants in Arm A will receive Len, 25 mg or 10 mg orally daily, on Days 1-21 of each 28-day cycle with Dex, 40 mgs weekly per oral (PO) on Days 1, 8, 15, and 22 of each cycle. Participants may continue treatment until PD, intolerable AEs, consent withdrawal, or death.
Drug: GSK2857916
Selected doses and schedules of GSK2857916, will be administered as infusion during Part 1 and Part 2, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone respectively.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg, orally, with GSK2857916 and dexamethasone, during Part 1 and Part 2.

Drug: Dexamethasone
Dexamethasone will be administered as 20 or 40 mg, orally with GSK2857916, and lenalidomide or bortezomib, during Part 1 and Part 2 respectively.

Experimental: Arm B, Part 1, GSK2857916 plus bortezomib plus dexamethasone
A mTPI design will guide Part 1 dose escalation. Up to 3 dose levels of GSK2857916 (2.5 mg/kg; 3.4 mg/kg; 1.9 mg/kg), and 2 alternate dosing schedules will be evaluated with a fixed dose of Bor/Dex. Cohorts will be recruited in blocks of 3 participants with up to 6 per dose level. Participants will enroll with at least 1 day between each participant's first dose of GSK2857916 to reduce the risk of exceeding MTD. To move to next dose level, at least 3 DLT evaluable participants will be reviewed. Participants in Arm B receive bortezomib, at a dose of 1.3 mg/m^2 (mg/square meters), approximately 1-hour post GSK2857916, on Days 1, 4, 8, and 11 of every 21-day cycle, for 8 cycles and dexamethasone at 20 mg PO, or intravenous (IV) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle. Participants also receive an antiviral for up to 8-cycles. After 8 cycles of combination therapy participants will receive GSK2857916 monotherapy until PD, intolerable AEs, consent withdrawal, or death.
Drug: GSK2857916
Selected doses and schedules of GSK2857916, will be administered as infusion during Part 1 and Part 2, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone respectively.

Drug: Dexamethasone
Dexamethasone will be administered as 20 or 40 mg, orally with GSK2857916, and lenalidomide or bortezomib, during Part 1 and Part 2 respectively.

Drug: Bortezomib
Bortezomib will be administered as 1.3 mg/m^2, as SC or IV, with GSK2857916 and dexamethasone, during Part 1 and Part 2 respectively.

Experimental: Arm A, Part 2, GSK2857916, Expansion
Part 2 of Arm A will further evaluate the safety and preliminary clinical activity of GSK2857916 with Len/Dex to identify the optimal dose(s) and schedules for combination treatment of GSK2857916 when administered with Len/Dex. The participants in Arm A will receive GSK2857916 , on Day 1 of each 28-Day cycle. Participants in Arm A will receive lenalidomide, at dose of 25 mg or 10 mg orally daily, on Days 1-21 of each 28-day cycle; with dexamethasone at a dose of 40 mg or 20 mg once weekly, orally on Days 1, 8, 15, and 22 of each cycle.
Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg, orally, with GSK2857916 and dexamethasone, during Part 1 and Part 2.

Drug: Dexamethasone
Dexamethasone will be administered as 20 or 40 mg, orally with GSK2857916, and lenalidomide or bortezomib, during Part 1 and Part 2 respectively.

Drug: GSK2857916
Selected dose levels and schedules of GSK2857916, will be administered in Part 2, as an infusion. It will be given with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, during Part 2.

Experimental: Arm B, Part 2, GSK2857916, Expansion
Part 2 of Arm B will further evaluate the safety and preliminary clinical activity of GSK2857916 with Bor/Dex to identify the optimal dose(s) and schedules for each arm of combination treatment of GSK2857916 when administered with Bor/Dex. The participants in Arm B will receive GSK2857916 , on Day 1 of each 21-Day cycle. Participants in Arm B will receive bortezomib, at a dose of 1.3 mg/m^2, subcutaneously (SC) or IV, given approximately 1 hour post GSK2857916, assuring participants stability, on Days 1, 4, 8, and 11 of every 21-day cycle, for 8 cycles; with dexamethasone at a dose of 20 mg orally, or IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle. Participants will also receive Acyclovir or other antiviral, for up to 8-cycles.
Drug: Dexamethasone
Dexamethasone will be administered as 20 or 40 mg, orally with GSK2857916, and lenalidomide or bortezomib, during Part 1 and Part 2 respectively.

Drug: Bortezomib
Bortezomib will be administered as 1.3 mg/m^2, as SC or IV, with GSK2857916 and dexamethasone, during Part 1 and Part 2 respectively.

Drug: GSK2857916
Selected dose levels and schedules of GSK2857916, will be administered in Part 2, as an infusion. It will be given with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, during Part 2.




Primary Outcome Measures :
  1. Number (percentage[%]) of particpant's with DLTs, Part 1 [ Time Frame: Up to 4.5 years ]
    The number (%) of participant's with DLT's will be reported.

  2. Number (%) of participants with AE's and serious adverse events (SAEs), Part 1 [ Time Frame: Up to 4.5 years ]
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect and other situations which involve medical or scientific judgment, and is associated with liver injury and impaired liver function The number (%) of participant experiencing SAE and AEs during Part 1 of the study will be reported.

  3. Number (%) of participants with electrocardiogram (ECG) parameters of potential clinical importance (PCI), Part 1 [ Time Frame: Up to 4.5 years ]
    Twelve-lead ECGs, will be performed, with the participant at designated time points, using an ECG machine, after 5 minutes of rest. The number (%) of participants with PCI values, will be reported.

  4. Number (%) of participants with abnormal hematology parameters, Part 1 [ Time Frame: Up to 4.5 years ]
    Blood samples will be collected to measure platelets, white blood cell (WBC count), red blood cell (RBC) count, reticulocyte count, hemoglobin, hematocrit, RBC indices, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), basophils, eosinophils, lymphocytes, monocytes and neutrophils. The number (%) of participants with abnormal hematology parameters will be reported.

  5. Number (%) of participants with abnormal clinical chemistry parameters, Part 1 [ Time Frame: Up to 4.5 years ]
    Blood samples will be collected to measure blood urea nitrogen (BUN), creatinine, glucose, sodium, magnesium, potassium, chloride, Total carbon dioxide (CO2), phosphorous, calcium, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, creatinine kinase (CK), total and direct bilirubin, uric acid, albumin, total protein, lactate dehydrogenase (LDH). The number (%) of participants with abnormal clinical chemistry parameters will be reported.

  6. Number (%) of participants with abnormal urinalysis parameters, Part 1 [ Time Frame: Up to 4.5 years ]
    Urine samples will be collected to measure specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick method at specified time points. The number (%) of participants with abnormal urinalysis parameters will be reported.

  7. Number (%) of participants with vital signs of PCI, Part 1 [ Time Frame: Up to 4.5 years ]
    The number (%) of participants with vital signs of PCI, for systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature and heart rate will be reported. Vitals will be measured after specific time points after at least 5 minutes of rest.

  8. Number (%) of participants with AEs and SAEs as a measure of safety in Part 2 [ Time Frame: Up to 4.5 years ]
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect and other situations which involve medical or scientific judgment, and is associated with liver injury and impaired liver function. The number (%) of participants experiencing SAE and AEs during Part 2 of the study will be reported.

  9. Summary of Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for multiple myeloma (MM), Part 2 [ Time Frame: Up to 4.5 years ]
    ORR defined as percentage (%) of participants achieving >=Partial Response (PR) as defined by the IMWG Uniform Response Criteria for MM.


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) for GSK2857916, Part 1, Treatment A [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6 and pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 28 days) ]
    Serial blood samples will be collected for pharmacokinetic (PK) analysis.

  2. Area under the curve (AUC) for GSK2857916, Part 1, Treatment A [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 28 days) ]
    Serial blood samples will be collected for PK analysis.

  3. Time to maximum plasma concentration (Tmax) for GSK2857916, Part 1, Treatment A [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6 and pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 28 days) ]
    Serial blood samples will be collected for PK analysis.

  4. Serum half-life (t1/2) for GSK2857916, Part 1, Treatment A [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6 and pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 28 days) ]
    Serial blood samples will be collected for PK analysis.

  5. Cmax for GSK2857916, Part 1, Treatment B [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; Cycle 1 Day 8; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 21 days) ]
    Serial blood samples will be collected for PK analysis.

  6. AUC for GSK2857916, Part 1, Treatment B [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; Cycle 1 Day 8; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  7. Tmax for GSK2857916, Part 1, Treatment B [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; Cycle 1 Day 8; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  8. t1/2 for GSK2857916, Part 1, Treatment B [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; Cycle 1 Day 8; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  9. Cmax for GSK2857916, Part 2, Treatment A [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6 and pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 28 days) ]
    Serial blood samples will be collected for PK analysis.

  10. AUC for GSK2857916, Part 2, Treatment A [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6 and pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 28 days) ]
    Serial blood samples will be collected for PK analysis.

  11. Tmax for GSK2857916, Part 2, Treatment A [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6 and pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 28 days) ]
    Serial blood samples will be collected for PK analysis.

  12. t1/2 for GSK2857916, Part 2, Treatment A [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6 and pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 28 days) ]
    Serial blood samples will be collected for PK analysis.

  13. Cmax for GSK2857916, Part 2, Treatment B [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; Cycle 1 Day 8; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  14. AUC for GSK2857916, Part 2, Treatment B [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; Cycle 1 Day 8; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  15. Tmax for GSK2857916, Part 2, Treatment B [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; Cycle 1 Day 8; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  16. t1/2 for GSK2857916, Part 2, Treatment B [ Time Frame: Pre-dose and at 2 hour post-infusion on Day 1 Cycle 1; Cycle 1 Day 8; pre-dose and post-dose on Day 1 of Cycle 2, Cycle 3, Cycle 6; pre-dose on Day 1 of Cycle 9 and Cycle 12 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  17. Cmax for Lenalidomide, Part 1, Treatment A [ Time Frame: At pre-dose, and 0.5, 1, 2, and 4 hour post dose on Day 1 of Cycle 1 (each cycle is 28 days) ]
    Serial blood samples will be collected for PK analysis.

  18. AUC for Lenalidomide, Part 1, Treatment A [ Time Frame: At pre-dose, and 0.5, 1, 2, and 4 hour post dose on Day 1 of Cycle 1 (each cycle is 28 days) ]
    Serial blood samples will be collected for PK analysis.

  19. Tmax for Lenalidomide, Part 1, Treatment A [ Time Frame: At pre-dose, and 0.5, 1, 2, and 4 hour post dose on Day 1 of Cycle 1 (each cycle is 28 days) ]
    Serial blood samples will be collected for PK analysis.

  20. t1/2 for Lenalidomide, Part 1, Treatment A [ Time Frame: At pre-dose, and 0.5, 1, 2, and 4 hour post dose on Day 1 of Cycle 1 (each cycle is 28 days) ]
    Serial blood samples will be collected for PK analysis.

  21. Cmax for Bortezomib, Part 1, Treatment B [ Time Frame: Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  22. AUC for Bortezomib, Part 1, Treatment B [ Time Frame: Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  23. Tmax for Bortezomib, Part 1, Treatment B [ Time Frame: Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  24. t1/2 for Bortezomib, Part 1, Treatment B [ Time Frame: Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (Each cycle is of 21 days) ]
    Serial blood samples, will be collected for PK analysis. The sampling beyond Cycle 12, was conducted at pre-dose every 6th Cycle.

  25. Cmax for Lenalidomide, Part 2, Treatment A [ Time Frame: At pre-dose, and 0.5 hour, 1, 2, and 4 hour post dose on Day 1 of Cycle 1 (each cycle is 28 days) ]
    Serial blood samples will be collected for PK analysis.

  26. AUC for Lenalidomide, Part 2, Treatment A [ Time Frame: At pre-dose, and 0.5 hour, 1, 2, and 4 hour post dose on Day 1 of Cycle 1 (each cycle is 28 days) ]
    Serial blood samples will be collected for PK analysis.

  27. Tmax for Lenalidomide, Part 2, Treatment A [ Time Frame: At pre-dose, and 0.5 hour, 1, 2, and 4 hour post dose on Day 1 of Cycle 1 (each cycle is 28 days) ]
    Serial blood samples will be collected for PK analysis.

  28. t1/2 for Lenalidomide, Part 2, Treatment A [ Time Frame: At pre-dose, and 0.5 hour, 1, 2, and 4 hour post dose on Day 1 of Cycle 1 (each cycle is 28 days) ]
    Serial blood samples will be collected for PK analysis.

  29. Cmax for Lenalidomide, Part 2, Treatment B [ Time Frame: Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (Each cycle is of 21 days) ]
    Serial blood samples will be collected for PK analysis.

  30. AUC for Lenalidomide, Part 2, Treatment B [ Time Frame: Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (Each cycle is of 21 days) ]
    Serial blood samples will be collected for PK analysis.

  31. Tmax for Lenalidomide, Part 2, Treatment B [ Time Frame: Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (Each cycle is of 21 days) ]
    Serial blood samples will be collected for PK analysis.

  32. t1/2 for Lenalidomide, Part 2, Treatment B [ Time Frame: Pre-dose and 5, 15, 30 minutes and 1, 2, 4, 6, 10, 24, 48, 72 hours post-dose on Day 1 of Cycle 1 (Each cycle is of 21 days) ]
    Serial blood samples will be collected for PK analysis.

  33. Number of participants with anti-drug antibodies (ADAs) against GSK2857916, Part 1, Treatment A [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2, 3, 6, 9, 12 (Each cycle is of 28 days) ]
    The number of participants with ADAs will be reported. All ADA samples will be collected prior to each infusion (at Cycle 1, 2, 3, 6, 9, 12) on the dosing days in Part 1, at the same time as the pre-dose GSK2857916, PK samples.

  34. Number of participants with ADAs, against GSK2857916, Part 1 treatment B [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2, 3, 6, 9, 12 (Each cycle is of 21 days) ]
    The number of participants with ADAs will be reported. All ADA samples will be collected prior to each infusion (at Cycle 1, 2, 3, 6, 9, 12) on the dosing days in Part 1, at the same time as the pre-dose GSK2857916, PK samples.

  35. Number of participants with ADAs, against GSK2857916, Part 2 Treatment A [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2, 3, 6, 9, 12 (Each cycle is of 28 days) ]
    The number of participants with ADAs will be reported. All ADA samples will be collected prior to each infusion (at Cycle 1, 2, 3, 6, 9, and Cycle 12) on the dosing days in Part 2 at the same time as the pre-dose GSK2857916 PK samples.

  36. Number of participants with ADAs, against GSK2857916, Part 2, Treatment B [ Time Frame: Pre-dose on Day 1 of Cycle 1, 2, 3, 6, 9, 12 (Each cycle is of 21 days) ]
    The number of participants with ADAs will be reported. All ADA samples will be collected prior to each infusion (at Cycle 1, 2, 3, 6, 9, and Cycle 12) on the dosing days in Part 2 at the same time as the pre-dose GSK2857916 PK samples.

  37. Change from Baseline in symptoms and impacts as measured by Ocular Surface Disease Index (OSDI), Part 1 [ Time Frame: Baseline and up to 4.5 years ]
    The OSDI, is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The OSDI has demonstrated good reliability, validity, sensitivity, and specificity, and can be used as a complement to other clinical and subjective measures of dry eye disease by providing a quantifiable assessment of dry eye symptom frequency and the impact of these symptoms on vision-related functioning. The OSDI will be measured at every 4-weeks, for Treatment A and every 3-weeks, for Treatment B.

  38. Change from Baseline in symptoms and impacts as measured by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), Part 1 [ Time Frame: Baseline and up to 4.5 years ]
    The NEI-VFQ-25, consists of a base set of 25 vision-targeted questions representing, 11 vision-related constructs, plus an additional single-item, general health rating question. These include, a global vision rating (1 item); difficulty with near vision activities (3 items); difficulty with distance vision activities (3 items); limitations in social functioning due to vision (2 items); role limitations due to vision (2 items); dependency on others due to vision (3 items); mental health symptoms due to vision (4 items); driving difficulties (3 items); limitations with peripheral vision (1 item), limitations with color vision (1 item); and Ocular pain (2 items). Scores will be measured, every 4-weeks, for Treatment and every 3-weeks, for Treatment B.

  39. Change from Baseline in symptoms and impacts as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE), Part 1 [ Time Frame: Baseline and up to 4.5 years ]
    The PRO-CTCAE is a participant-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 80 symptomatic toxicities drawn from the CTCAE.

  40. Change from Baseline in symptoms and impacts as measured by OSDI, Part 2 [ Time Frame: Baseline and up to 4.5 years ]
    The ocular surface disease index (OSDI), is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The OSDI has demonstrated good reliability, validity, sensitivity, and specificity, and can be used as a complement to other clinical and subjective measures of dry eye disease by providing a quantifiable assessment of dry eye symptom frequency and the impact of these symptoms on vision-related functioning. The OSDI will be measured at every 4-weeks, for Treatment A and every 3-weeks, for Treatment B.

  41. Change from Baseline in symptoms and impacts as measured by NEI-VFQ-25, Part 2 [ Time Frame: Baseline and up to 4.5 years ]

    The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) consists of a base set of 25 vision-targeted questions representing, 11 vision-related constructs, plus an additional single-item, general health rating question. These include, a global vision rating (1 item); difficulty with near vision activities (3 items); difficulty with distance vision activities (3 items); limitations in social functioning due to vision (2 items); role limitations due to vision (2 items); dependency on others due to vision (3 items); mental health symptoms due to vision (4 items); driving difficulties (3 items); limitations with peripheral vision (1 item), limitations with color vision (1 item); and Ocular pain (2 items).

    The NEI-VFQ-25 will be measured at every 4-weeks, for Treatment A and every 3-weeks, for Treatment B.


  42. Change from Baseline in symptoms and impacts as measured by PRO-CTCAE, Part 2 [ Time Frame: Baseline and up to 4.5 years ]
    The Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events is a participant-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 80 symptomatic toxicities drawn from the CTCAE.

  43. Number of participants with AE's and SAE's, Part 2 [ Time Frame: Up to 4.5 years ]
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect and other situations which involve medical or scientific judgment, and is associated with liver injury and impaired liver function The number of participants experiencing SAE and AEs during, Part 2 of the study will be reported.

  44. Number of participants with AE's of special interest (AESI), Part 1 [ Time Frame: Up to 4.5 years ]
    The AE's of special interest, for GSK2857916 are corneal events, thrombocytopenia and infusion related reactions. The severity of other AESI will be graded utilizing the National Cancer Institute- Common Toxicity Criteria for Adverse Events.

  45. Number of participants with AE's of special interest (AESI), Part 2 [ Time Frame: Up to 4.5 years ]
    The AE's of special interest, for GSK2857916 are corneal events, thrombocytopenia and infusion related reactions. The severity of other AESI will be graded utilizing the National Cancer Institute- Common Toxicity Criteria for Adverse Events.

  46. Number of participants with ophthalmic findings on ophthalmic exam, Part 1 [ Time Frame: Up to 4.5 years ]
    The ophthalmic examinations will be done, by an ophthalmologist (or optometrist), to assess participants who develop corneal events, during the study.

  47. Number of participants with ophthalmic findings on ophthalmic exam, Part 2 [ Time Frame: Up to 4.5 years ]
    The ophthalmic examinations will be done, by an ophthalmologist (or optometrist), to assess participants who develop corneal events, during the study.

  48. Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30), Part 1 [ Time Frame: Baseline and Up to 4.5 years ]
    EORTC QLQ-C30, is a 30-item questionnaire containing both single- and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/QoL scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). Scores for each scale and single-item measure. A high score for functional scales and for Global Health Status/QoL, represent better functioning ability or HRQoL, whereas a high score for symptom scales and single items represents significant symptomatology.

  49. Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20), Part 1 [ Time Frame: Baseline and Up to 4.5 years ]
    QLQ-MY20, module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment (DSSE), Future Perspective, and Body Image (FPBI). Three of four QLQ-MY20 domains, are multi-item scales: Disease Symptoms (bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity); Side effects of treatment (drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes); and Future perspective (worry about death and health in future, and thinking about illness). The Body Image scale is single-item scale that addresses physical attractiveness. A high score for DSSE, represents a high level of symptomatology or problems, whereas high score for FPBI, represents better outcomes.

  50. Change from Baseline in HRQoL as measured by EORTC QLQ-C30, Part 2 [ Time Frame: Baseline and Up to 4.5 years ]
    EORTC QLQ-C30, is a 30-item questionnaire containing both single- and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/QoL scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). A high score for functional scales and for Global Health Status/QoL, represent better functioning ability or HRQoL, whereas a high score for symptom scales and single items represents significant symptomatology.

  51. Change from Baseline in HRQoL as measured by EORTC, 20-Item MM Module (QLQ-MY20), Part 2 [ Time Frame: Baseline and Up to 4.5 years ]
    QLQ-MY20, module comprises 20 questions that address four myeloma-specific HRQoL domains: DSSE, FPBI. Three of four QLQ-MY20 domains, are multi-item scales: Disease Symptoms (bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity); Side effects of treatment (drowsiness, thirst, feeling ill, dry mouth, hair loss, upset by hair loss, tingling hands or feet, restlessness/agitation, acid indigestion/heartburn, and burning or sore eyes); and Future perspective (worry about death and health in future, and thinking about illness). The Body Image scale is single-item scale that addresses physical attractiveness. A high score for DSSE, represents a high level of symptomatology or problems, whereas high score for FPBI, represents better outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of giving signed informed consent.
  • Male or female, 18 years or older (at the time consent is obtained).
  • Have confirmed diagnosis of Multiple Myeloma (MM) as defined by the IMWG.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 for Arm A and 0 to 2 for Arm B.
  • Have undergone stem cell transplant (SCT), or are considered transplant ineligible.
  • Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy according to the IMWG criteria.
  • Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
  • Participants with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Participant meets the remainder of the eligibility criteria.
  • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be <= Grade 1 at the time of enrollment, except for alopecia. Participants with Grade 2 neuropathy can be enrolled into Len/Dex treatment arm, but not into Bor/Dex treatment arm.
  • Adequate organ system functions as defined by the laboratory assessments.
  • The contraception's used by female participant's be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. WOCBP must have 2 negative highly sensitive serum pregnancy tests, as required by local regulations (first within 14 days of Cycle 1 Day 1 and the second one within 24 hours of dosing on Cycle1 Day1) and agree to use effective contraception during the study and for 120 days after the last dose of study medication; Additional requirements for pregnancy testing during and after study intervention (i.e., REMS program for WOCBP taking lenalidomide).The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Male participant's using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male participants must agree to refrain from donating sperm and either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent from the time of first dose of study until 140 days after the last dose of study treatment to allow for clearance of any altered sperm: OR Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP who is not currently pregnant. If the female partner of the male participant is pregnant at the time of enrollment, or becomes pregnant during the trial, the male participant must agree to remain abstinent (if it is consistent with their preferred and usual lifestyle) or use a male condom. Additional criteria WOCBP participants in Arm A: Due to lenalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a restricted distribution program called the REVLIMID (Lenalidomide) REMS program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 120 days following discontinuation of treatment.

Exclusion Criteria:

  • Systemic anti-myeloma therapy (including systemic steroids) within 14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
  • Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
  • Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
  • Prior allogenic stem cell transplant. Note: participants who have undergone syngeneic transplant will be allowed only if they have no history and no currently active, graft versus host disease (GvHD) - Evidence of active mucosal or internal bleeding.
  • Any major surgery within the last four weeks.
  • Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
  • Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
  • Participants with invasive malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease.Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
  • Evidence of cardiovascular risk including any of the following: a. Corrected QT (QTc) interval >=480 millisecond (msec); Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension.
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to GSK2857916, or any of the components of the study treatment.
  • Pregnant or lactating female.
  • Active infection requiring treatment.
  • Known HIV infection.
  • Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
  • Current corneal disease except for mild punctuate keratopathy.
  • Positive hepatitis C antibody test result or positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study treatment. NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.
  • Current corneal disease except for mild punctuate keratopathy.
  • Additional Exclusion Criteria for participants Assigned to Treatment A: Participants unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs.
  • Additional Exclusion Criteria for Participants Assigned to Treatment B: Unacceptable AEs from previous bortezomib treatment; Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment; Intolerance or contraindications to anti-viral prophylaxis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544281


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Alabama
GSK Investigational Site Recruiting
Birmingham, Alabama, United States, 35294
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Racquel Dawn Innis-Shelton         
United States, Georgia
GSK Investigational Site Recruiting
Atlanta, Georgia, United States, 30322
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ajay Nooka         
United States, Indiana
GSK Investigational Site Recruiting
Indianapolis, Indiana, United States, 46202
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rafat Abonour         
United States, Missouri
GSK Investigational Site Recruiting
Saint Louis, Missouri, United States, 63110
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Keith Stockerl-Goldstein         
United States, Nebraska
GSK Investigational Site Recruiting
Grand Island, Nebraska, United States, 68802
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ryan Ramaekers         
United States, New Jersey
GSK Investigational Site Recruiting
Hackensack, New Jersey, United States, 07601
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: David S Siegel         
United States, South Carolina
GSK Investigational Site Recruiting
Greenville, South Carolina, United States, 29605
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Elizabeth Cull         
Australia, Victoria
GSK Investigational Site Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hang Quach         
GSK Investigational Site Recruiting
Melbourne, Victoria, Australia, 3000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Amit Khot         
GSK Investigational Site Recruiting
Melbourne, Victoria, Australia, 3004
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Andrew Spencer         
Australia, Western Australia
GSK Investigational Site Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bradley Augustson         
Sponsors and Collaborators
GlaxoSmithKline
Iqvia Pty Ltd
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03544281     History of Changes
Other Study ID Numbers: 207497
2017-004689-93 ( EudraCT Number )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available, within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided, after a research proposal is submitted and has submitted approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Relapsed / Refractory Multiple Myeloma
Dose escalation
Antibody-Drug Conjugate
Dose expansion
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Lenalidomide
Bortezomib
BB 1101
Antibodies
Immunoglobulins
Immunoconjugates
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones