Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma (DREAMM 9)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091126
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. This will be every cycle of VRd, every other cycle of VRd, or every third cycle of VRd. Belantamab may also be given as a 'split' dose, which is 50% of the dose on Day 1 and 50% of the dose on Day 8 of a cycle. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Belantamab mafodotin Drug: Bortezomib Drug: Lenalidomide Drug: Dexamethasone Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The study will evaluate different doses/dose schedules of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone, (VRd) in up to 8 cohorts and will determine the Recommended Phase 3 dose (RP3D).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma
Actual Study Start Date : December 18, 2019
Estimated Primary Completion Date : December 9, 2021
Estimated Study Completion Date : January 7, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/Rd
Participants will receive 1.9 milligram /kilogram (mg/kg) three -weekly (Q3W) dose of belantamab mafodotin intravenously (IV) on Day 1 of every 21-day cycle for the first 8 cycles in combination with VRd. From cycle 9 onwards, participants will receive 1.9 mg/kg four-weekly (Q4W) dose of belantamab mafodotin intravenously on Day 1 of every 28-day cycle in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Drug: Dexamethasone
Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Experimental: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/Rd
Participants will receive 1.4 mg/kg six-weekly (Q6W) dose of belantamab mafodotin intravenously on Day 1 of every other 21-day cycle for the first 8 cycles in combination with VRd. From cycle 9 onwards, participants will receive 1.4 mg/kg eight-weekly (Q8W) dose of belantamab mafodotin intravenously on Day 1 of every other 28-day cycle in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Drug: Dexamethasone
Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Experimental: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/Rd
Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin intravenously on Day 1 of every other 21-day cycle for the first 8 cycles in combination with VRd. From cycle 9 onwards, participants will receive 1.9 mg/kg Q8W dose of belantamab mafodotin intravenously on Day 1 of every other 28-day cycle in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Drug: Dexamethasone
Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Experimental: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/Rd
Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin intravenously on Day 1 of every 21-day cycle for the first 8 cycles in combination with VRd. From cycle 9 onwards, participants will receive 1.0 mg/kg Q4W dose of belantamab mafodotin intravenously on Day 1 of every 28-day cycle in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Drug: Dexamethasone
Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Experimental: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/Rd
Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin intravenously on Day 1 of every 21-day cycle for the first 8 cycles in combination with VRd. From cycle 9 onwards, participants will receive 1.4 mg/kg Q4W dose of belantamab mafodotin intravenously on Day 1 of every 28-day cycle in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Drug: Dexamethasone
Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Experimental: Cohort 6: belantamab mafodotin 1.9 or 2.5 mg/kg Q9/12W+VRd/Rd
Based on emerging data, participants will receive either 1.9 mg/kg or 2.5 mg/kg Q9W dose of belantamab mafodotin intravenously on Day 1 of every third 21-day cycle for the first 8 cycles in combination with VRd. From cycle 9 onwards, participants will receive either 1.9 mg/kg or 2.5 mg/kg Q12W dose of belantamab mafodotin intravenously on Day 1 of every third 28-day cycle in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Drug: Dexamethasone
Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Experimental: Cohort7:belantamab mafodotin 1.9/2.5mg/kg Q6/8W (split)+VRd/Rd
Based on emerging data, participants will receive a total dose of either 1.9 mg/kg or 2.5 mg/kg of belantamab mafodotin intravenously (split in to two equal doses of 0.95 mg/kg or 1.25 mg/kg to be given on Day 1 and Day 8) Q6W of every other 21-day cycle for the first 8 cycles in combination with VRd. From cycle 9 onwards, participants will receive a total dose of either 1.9 mg/kg or 2.5 mg/kg of belantamab mafodotin intravenously (split in to two equal doses of 0.95 mg/kg or 1.25 mg/kg to be given on Day 1 and Day 8) Q8W of every other 28-day cycle in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Drug: Dexamethasone
Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

Experimental: Cohort 8: belantamab mafodotin 2.5 mg/kg Q6/8W + VRd/Rd
Based on emerging data, participants will receive 2.5 mg/kg Q6W dose of belantamab mafodotin intravenously on Day 1 of every other 21-day cycle for the first 8 cycles in combination with VRd. From cycle 9 onwards, participants will receive 2.5 mg/kg Q8W dose of belantamab mafodotin intravenously on Day 1 of every other 28-day cycle in combination with Rd.
Drug: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as intravenous infusion.

Drug: Bortezomib
Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.

Drug: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.

Drug: Dexamethasone
Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.




Primary Outcome Measures :
  1. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Treatment cycle 1 to 3 (each cycle of 21 days) ]
    The number of participants with DLTs will be reported.

  2. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to an average of 54 months ]
    AEs and SAEs will be collected.


Secondary Outcome Measures :
  1. Lenalidomide relative dose intensity (RDI ) of treatment with belantamab mafodotin in combination with VRd [ Time Frame: 4 treatment cycles (each cycle of 21 days) ]
    RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.

  2. Bortezomib RDI of treatment with belantamab mafodotin in combination with VRd [ Time Frame: 4 treatment cycles (each cycle of 21 days) ]
    RDI of treatment with belantamab mafodotin in combination with VRd will be analyzed.

  3. Cumulative administered dose of belantamab mafodotin treatment in combination with VRd [ Time Frame: 4 treatment cycles (each cycle of 21 days) ]
    Cumulative administered dose of belantamab mafodotin in treatment in combination with VRd will be analyzed.

  4. Maximum plasma concentration (Cmax) of belantamab mafodotin [ Time Frame: Up to an average of 52 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  5. Cmax of total monoclonal antibody (mAb) [ Time Frame: Up to an average of 52 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  6. Cmax of microtubule inhibitor monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) [ Time Frame: Up to an average of 52 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  7. Area under the concentration time curve (AUC) of belantamab mafodotin [ Time Frame: Up to an average of 52 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  8. AUC of monoclonal antibody (mAb) [ Time Frame: Up to an average of 52 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  9. AUC of cys-mcMMAF [ Time Frame: Up to an average of 52 months ]
    Blood samples will be collected at indicated time points for pharmacokinetic analysis.

  10. Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin [ Time Frame: Up to an average of 52 months ]
    Serum samples for the analysis of anti-belantamab mafodotin antibodies will be collected. The samples will be tested for anti-belantamab mafodotin antibodies using a tiered-testing scheme consisting of validated screening, confirmation, and titration assays.

  11. Titers of ADAs against belantamab mafodotin [ Time Frame: Up to an average of 52 months ]
    Serum samples for the analysis of anti-belantamab mafodotin antibodies will be collected. The samples will be tested for anti-belantamab mafodotin antibodies using a tiered-testing scheme consisting of validated screening, confirmation, and titration assays.

  12. Overall Response Rate (ORR) [ Time Frame: Up to 52 months ]
    ORR is defined as the percentage of participants with a confirmed partial response (PR) or better based on the response assessed by the investigator using International Myeloma Working Group (IMWG) criteria.

  13. Complete Response Rate (CRR) [ Time Frame: Up to 52 months ]
    CRR is defined as the percentage of participants with a confirmed complete response (CR) or better based on the response assessed by the investigator using IMWG criteria.

  14. Rate of Very Good Partial Response (VGPR) or better [ Time Frame: Up to 52 months ]
    Rate of VGPR or better is defined as the percentage of participants with a confirmed VGPR or better based on the response assessed by the investigator using IMWG criteria.



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.


Layout table for eligibility information
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 over 18 years of age inclusive, at the time of signing the informed consent.
  • Diagnosis of multiple myeloma with a requirement for treatment as documented per international myeloma working group (IMWG) criteria.
  • Must have at least one aspect of measurable disease, defined as one of the following:
  • Urine M-protein excretion >=200 mg/24 hours (>=0.2 gram [g]/24 hours), or
  • Serum M-protein concentration >=0.5 grams per deciliter (g/dL) (>=5.0 gram per liter [g/L]), or
  • Serum free light chain (FLC) assay: involved FLC level >=10 milligrams per deciliter (mg/dL) (>=100 milligram per liter [mg/L]) and an abnormal serum free light chain ratio (<0.26 or >1.65).
  • Not a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to presence of significant comorbid condition(s), such as cardiac, pulmonary or other major organ dysfunction that are likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation, as judged by the investigator.
  • Eastern cooperative oncology group (ECOG) status of 0-2
  • Adequate organ system functions as defined by the laboratory assessments listed as following: Absolute neutrophil count (ANC) >=1.5 x 10^9/L; Hemoglobin >=8.0 g/dL; Platelets >=75 x 10^9/L; Total bilirubin <=1.5 x upper limit of normal (ULN); (Isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%); Alanine aminotransferase (ALT) <=2.5 x ULN; eGFR >=30 mL/minute/1.73 meter^2; Urine Dipstick for protein OR Albumin/creatinine ratio (from spot urine)- Negative/trace (if >=1 plus only eligible if confirmed <=500 mg/gram (56 mg/millimoles [mmol]) by albumin/creatinine ratio (spot urine from first void); Left Ventricular Ejection Fraction (LVEF) by echocardiogram (ECHO) of >=35% participants with low LVEF (per institutional standards), consider referring to cardiology per local standards of care.
  • Male and/or female
  • Contraceptive use by women should be consistent with local regulations regarding the 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 1 of the following conditions applies:
  • Is NOT a woman of childbearing potential (WOCBP) or Due to lenalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, and bortezomib having the potential to cause fetal harm, WOCBP participants will be eligible if they commit to either: abstain continuously from heterosexual sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR to use birth control as follows: Two methods of reliable birth control (one method that is highly effective and one additional effective (barrier) method), beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use one method of reliable birth control that is highly effective for a further 3 months following discontinuation of belantamab mafodotin, or a further 6 months following discontinuation of bortezomib, whichever is longer. WOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during treatment, during dose interruptions and for 28-days following the last dose of lenalidomide, 4 months following discontinuation of belantamab mafodotin treatment or 7-months following the last dose of bortezomib, whichever is longer. Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing the start of lenalidomide therapy.

The participant should not receive lenalidomide until the investigator has verified that the results of these pregnancy tests are negative. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. 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.

  • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • Male participants are eligible to participate if they agree to the following from the time of first dose of study treatment until 28-days after the last dose of lenalidomide, 4-months after the last dose of bortezomib, or 6 months after the last dose of belantamab mafodotin, whichever is longer, to allow for clearance of any altered sperm: Refrain from donating sperm - Plus 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 OR Must agree to use contraception/barrier as detailed below: Agree to use a male condom, even if they have undergone a successful vasectomy, 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. Male participants should also use a condom when having sexual intercourse with pregnant females.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Smoldering multiple myeloma (SMM).
  • Prior systemic therapy for multiple myeloma, or SMM. NOTE: An emergency course of steroids (defined as no greater than 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. NOTE: Focal palliative radiation is permitted prior to enrollment, provided that it occurred at least 2 weeks prior to the first dose of study drug, that the participant has recovered from radiation-related toxicities, and that the participant did not require corticosteroids for radiation-induced adverse events.
  • Participant is eligible for high dose chemotherapy with ASCT, as determined by a frailty score of 0 as assessed by the IMWG frailty index.
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) Version 5.
  • Major surgery within 4 weeks prior to the first dose of study drug.
  • Presence of active renal condition (infection, requirement for dialysis or any other significant condition that could affect participant's safety). Participants with isolated proteinuria resulting from multiple myeloma (MM) are eligible, provided they fulfil 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.
  • Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.
  • Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the Investigator's assessment).
  • Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are surgically treated cervical carcinoma in situ, or any other malignancy that 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 following: Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or third 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 (NYHA) functional classification system; Uncontrolled hypertension.
  • Active infection requiring treatment.
  • Known human immunodeficiency virus (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. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
  • Positive hepatitis C antibody test result.
  • Current corneal epithelial disease except for mild punctate keratopathy. Note: Participants with mild punctate keratopathy are allowed.
  • Intolerance or contraindications to anti-viral prophylaxis.
  • Unable to tolerate antithrombotic prophylaxis.
  • AL amyloidosis (light chain amyloidosis), active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) syndrome or active plasma cell leukemia at the time of screening.
  • Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
  • Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
  • Plasmapheresis within 7 days prior to the first dose of study drug.

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): NCT04091126


Contacts
Layout table for location contacts
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
Layout table for location information
United States, Kansas
GSK Investigational Site Recruiting
Westwood, Kansas, United States, 66205
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: Al-Ola Abdallah         
United States, North Carolina
GSK Investigational Site Recruiting
Charlotte, North Carolina, United States, 28204
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: Saad Usmani         
United States, Wisconsin
GSK Investigational Site Recruiting
Madison, Wisconsin, United States, 53792
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: Natalie Callander         
Australia, New South Wales
GSK Investigational Site Recruiting
Waratah, New South Wales, Australia, 2298
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: Wojciech Janowski         
Australia, Victoria
GSK Investigational Site Recruiting
Clayton, Victoria, Australia, 3168
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: Michael Low         
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         
Canada, Alberta
GSK Investigational Site Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
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: Irwindeep Sandhu         
Canada, Ontario
GSK Investigational Site Recruiting
London, Ontario, Canada, N6A 5W9
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: Martha Louzada         
GSK Investigational Site Recruiting
Ottawa, Ontario, Canada, K1H 8L6
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: Arleigh McCurdy         
France
GSK Investigational Site Recruiting
Nantes cedex 1, France, 44093
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: Philippe Moreau         
GSK Investigational Site Recruiting
Rennes cedex 9, France, 35033
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: Olivier Decaux         
Germany
GSK Investigational Site Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
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: Marc Raab         
GSK Investigational Site Recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076
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: Britta Besemer         
GSK Investigational Site Recruiting
Schwerin, Mecklenburg-Vorpommern, Germany, 19049
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: Andreas Guenther         
GSK Investigational Site Recruiting
Hamburg, Germany, 20246
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: Katja Weisel         
Italy
GSK Investigational Site Recruiting
Bologna, Emilia-Romagna, Italy, 40138
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: Michele Cavo         
GSK Investigational Site Recruiting
Roma, Lazio, Italy, 00161
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: Maurizio Martelli         
GSK Investigational Site Recruiting
Milano, Italy, 20122
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: Luca Baldini         
Korea, Republic of
GSK Investigational Site Recruiting
Seoul, Korea, Korea, Republic of, 137-701
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: Chang Ki Min         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 03080
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: Youngil Koh         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 03722
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: Jin Seok Kim         
Spain
GSK Investigational Site Recruiting
Barcelona, Spain, 08036
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: Laura Rosinol Dachs         
GSK Investigational Site Recruiting
Madrid, Spain, 28027
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: Paula Rodriguez Otero         
GSK Investigational Site Recruiting
Pamplona, Spain, 31008
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: Paula Rodriguez Otero         
GSK Investigational Site Recruiting
Pozuelo De Alarcón/Madrid, Spain, 28223
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: Aránzazu Alonso Alonso         
United Kingdom
GSK Investigational Site Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
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: Matthew Jenner         
GSK Investigational Site Recruiting
Leicester, United Kingdom, LE1 5WW
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: Mamta Garg         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04091126    
Other Study ID Numbers: 209664
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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, 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Bortezomib
Lenalidomide
dexamethasone
VRd
Belantamab mafodotin
Newly diagnosed multiple myeloma
RP3D
DREAMM 9
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Lenalidomide
Bortezomib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors