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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Active, not recruiting
Phase 2


Multiple Myeloma


Drug: Belantamab mafodotin

Study type


Funder types



2021-004151-16 (EudraCT Number)

Details and patient eligibility


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.


177 patients




18+ years old


No Healthy Volunteers

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

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

177 participants in 5 patient groups

Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
Experimental group
Drug: Belantamab mafodotin
Cohort 2: Participants receiving belantamab mafodotin at DL 2
Experimental group
Drug: Belantamab mafodotin
Cohort 3: Participants receiving belantamab mafodotin at DL 3
Experimental group
Drug: Belantamab mafodotin
Cohort 4: Participants receiving belantamab mafodotin at DL 4
Experimental group
Drug: Belantamab mafodotin
Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification
Experimental group
Drug: Belantamab mafodotin

Trial contacts and locations



Central trial contact

EU GSK Clinical Trials Call Center; US GSK Clinical Trials Call Center

Data sourced from

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