Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM 14)

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Full 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)
Myeloma stage or condition:
Multiple Myeloma
Study phase:
Phase 2
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.
Detailed Description:
Not available
Drug : Belantamab mafodotin

Belantamab mafodotin will be administered.

Study Arms:
Experimental : Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
Experimental : Cohort 2: Participants receiving belantamab mafodotin at DL 2
Experimental : Cohort 3: Participants receiving belantamab mafodotin at DL 3
Experimental : Cohort 4: Participants receiving belantamab mafodotin at DL 4
Experimental : Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification
Study Type:
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Belantamab mafodotin will be administered using various dosing regimens.
Primary Purpose: Treatment
Masking: None (Open Label)
Masking Description: It is an open label study
Recruitment status:
Eligibility 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
Locations / Centres:

GSK Investigational Site, Oshawa, Ontario – Recruiting

GSK Investigational Site, Toronto, Ontario – Recruiting

GSK Investigational Site, Montreal, Quebec – Recruiting

GSK Investigational Site, Montréal, Quebec – Recruiting

Name: US GSK Clinical Trials Call Center
Phone: 877-379-3718
Email: [email protected]
First posted:
Actual start date:
March 3, 2022
Last updated:
Estimated enrollment:
Estimated completion date:
Estimated primary completion date:
Multiple Myeloma
18 Years-N/A
Accepts healthy volunteers:
Listed location countries:
Korea, Republic of
United Kingdom
United States
NCT number:
Other study ID numbers:
Has Data monitoring committee:
U.S. FDA-regulated product:
IPD Sharing Statement :
Responsible party:
Study sponsor:
GSK Clinical Trials GlaxoSmithKline
Protocol Registration and Results System:
Verification date: