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Trial record 1 of 1 for:    NCT05064358
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Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM 14)

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ClinicalTrials.gov Identifier: NCT05064358
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : April 12, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Belantamab mafodotin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Belantamab mafodotin will be administered using various dosing regimens.
Masking: None (Open Label)
Masking Description: It is an open label study
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)
Actual Study Start Date : March 3, 2022
Estimated Primary Completion Date : May 13, 2024
Estimated Study Completion Date : September 6, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Belantamab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1 Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Experimental: Cohort 2: Participants receiving belantamab mafodotin at DL 2 Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Experimental: Cohort 3: Participants receiving belantamab mafodotin at DL 3 Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Experimental: Cohort 4: Participants receiving belantamab mafodotin at DL 4 Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Experimental: Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rate of Grade ≥2 Corneal events according to the keratopathy visual acuity (KVA) scale [ Time Frame: Up to 12 months ]
    KVA scale is used to grade the corneal events from Grade 0-4. KVA grading is a composite score considering corneal exam findings (ranging from clear cornea [Grade 0] to corneal ulcer [Grade 4]), as well as changes in visual acuity (ranging from no change from Baseline in visual acuity [Grade 0] to visual acuity worse than 1.0 logarithm of the minimum angle of resolution ([logMAR] (20/200) [Grade 4]). The KVA grade is driven by the most severe finding.


Secondary Outcome Measures :
  1. Cumulative event rate of corneal events to Week 16 (KVA scale) [ Time Frame: Up to Week 16 ]
  2. Incidence rate of corneal events by grade (KVA scale) [ Time Frame: Up to 12 months ]
    KVA scale is used to grade the corneal events from Grade 0-4. KVA grading is a composite score considering corneal exam findings (ranging from clear cornea [Grade 0] to corneal ulcer [Grade 4]), as well as changes in visual acuity (ranging from no change from Baseline in visual acuity [Grade 0] to visual acuity worse than 1.0 logMAR (20/200) [Grade 4]). The KVA grade is driven by the most severe finding.

  3. Exposure adjusted incidence rate of corneal events by grade (KVA scale) [ Time Frame: Up to 12 months ]
    The exposure adjusted incidence rate is defined as the number of participants with corneal events divided by the total exposure in subject years among participants in the respective treatment group at risk of an initial occurrence of the event.

  4. Median duration of dose delay [ Time Frame: Up to 12 months ]
    Median duration of dose delay is defined as the median duration in time of all the dose delays in the respective treatment group.

  5. Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to corneal events [ Time Frame: Up to 12 months ]
  6. Cumulative incidence of corneal events by grade [ Time Frame: Up to 12 months ]
    Cumulative incidence of corneal events by grade is calculated using the KVA scale, as the number of new events divided by the total number of individuals in the population at risk for a specific time interval.

  7. Toxicity Index score by assessment/visit [ Time Frame: Up to 12 months ]
    Toxicity Index score is defined as a function of the ordered toxicity grades, where the toxicity grades are represented in descending order by the sequence.

  8. Duration of corneal events [ Time Frame: Up to 12 months ]
    Duration of corneal events is defined as the sum of the duration of all the corneal events of a participant.

  9. Percentage of time on study with corneal events [ Time Frame: Up to 12 months ]
    Percentage of time on study with corneal events is defined as the duration of corneal events divided by the total amount of time that a participant is on the study in percentage.

  10. Change in best corrected visual acuity (BCVA) [ Time Frame: Up to 12 months ]
    BCVA will be assessed as per Snellen (or Snellen-equivalent) chart.

  11. Overall response rate (ORR) [ Time Frame: Up to 12 months ]
    Percentage of participants with a confirmed partial response (PR) or better per International Myeloma Working Group (IMWG) criteria.

  12. Percentage of participants with very good partial response (VGPR) or better [ Time Frame: Up to 12 months ]
  13. Time to response (TTR) [ Time Frame: Up to 12 months ]
    Time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.

  14. Duration of response (DoR) [ Time Frame: Up to 12 months ]
    Time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to any cause.

  15. Time to progression (TTP) [ Time Frame: Up to 12 months ]
    Time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD.

  16. Progression-free survival (PFS) [ Time Frame: Up to 12 months ]
    Time from the date of randomization until the earliest date of documented PD (according to IMWG Response Criteria) or death due to any cause.

  17. Overall survival (OS) [ Time Frame: Up to 12 months ]
    Time from the date of randomization until death due to any cause.

  18. Number of participants with AEs and serious AEs (SAEs) [ Time Frame: Up to 12 months ]
  19. Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis laboratory parameters [ Time Frame: Up to 12 months ]
  20. Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to any AEs [ Time Frame: Up to 12 months ]
  21. Maximum concentration (Cmax) of belantamab mafodotin [ Time Frame: Up to 12 months ]
  22. Time taken to reach Cmax (Tmax) of belantamab mafodotin [ Time Frame: Up to 12 months ]
  23. Area under the concentration time-curve (AUC) of belantamab mafodotin [ Time Frame: Up to 12 months ]
  24. Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin [ Time Frame: Up to 12 months ]
  25. Titers of ADAs against belantamab mafodotin [ Time Frame: Up to 12 months ]

Eligibility Criteria
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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:

  • Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
  • France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
  • Participant has measurable disease per modified IMWG criteria.
  • Life expectancy of at least 6 months, in the opinion of the investigator.
  • Male and female participants agree to abide by protocol-defined contraceptive requirements.
  • Participant is capable of giving signed informed consent.
  • Participant meets country-specific inclusion criteria described in the protocol.

Exclusion Criteria:

  • Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
  • Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
  • Evidence of active mucosal or internal bleeding.
  • Presence of an active renal condition.
  • Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.
  • Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for >2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
  • Evidence of cardiovascular risk as per the protocol criteria.
  • Pregnant or lactating female.
  • Active infection requiring antibiotic, antiviral, or antifungal treatment.
  • Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
  • Hepatitis B and C will be excluded unless the criteria in protocol can be met.
  • Cirrhosis or current unstable liver or biliary disease.
  • Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).
  • Total Bilirubin >1.5×ULN.
  • Systemic anti-MM therapy within <=14 days or 5 half-lives, whichever is shorter.
  • Systemic therapy with high dose steroids within <=14 days before the first dose of study treatment.
  • Prior allogenic stem cell transplant.
  • Prior treatment with a monoclonal antibody <=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted.
  • Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment.
  • Treatment with an antibody-drug conjugate.
  • Participant has received any major surgery <=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery.
  • Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count <1.0×10^9/L, b. Hemoglobin <8 gram/deciliter (g/dL), c. Platelet count <50×10^9/L, d. Spot urine (albumin/creatinine ratio) >500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 meter square (mL/min/1.73m^2).
  • UK specific: a. Absolute neutrophil count <1.5×10^9/L, c. Platelet count <75×10^9/L
Contacts and Locations
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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): NCT05064358


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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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05064358    
Other Study ID Numbers: 209628
2021-004151-16 ( EudraCT Number )
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: April 12, 2023
Last Verified: April 2023
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, a key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received 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:
Antibody drug conjugate
Belantamab mafodotin
BLENREP
DREAMM14
 GSK2857916
Alternative dosing
Relapsed or refractory multiple myeloma
RRMM
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