Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

Key facts

Study ID

NCT04126200

Run by

GlaxoSmithKline

People needed

208

Starts

2019-10-07

Expected to finish

2027-03-11

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.
• Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG.
• Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
• Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was >100 days prior to study enrolment and with no active infection(s).
• Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (<=)2 is due solely to skeletal complications and/or skeletal pain due to MM.
• Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (>=)0.5 gram per deciliter (>=5 gram per liter) or Urine M-protein >=200 mg per 24 hours or Serum free light chain (FLC) assay: Involved FLC level >=10 mg per deciliter (>=100 mg per Liter) and an abnormal serum FLC ratio (<0.26 or >1.65).
• Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV DNA undetectable during screening.
• Participants who are currently receiving physiological doses oral steroids (<10 mg/day), inhaled steroids or ophthalmalogical steroids.
• Inclusion Criteria Specific to Sub-study 6 and7:
• Participants with contraception requirements specific to Sub-study 6 and 7 respectively.
• Participants with platelets value for Adequate Organ System Function is ≥75 × 10\^9/L.

You may not qualify if…

• Participants with current corneal epithelial disease except mild punctate keratopathy.
• Participants with evidence of cardiovascular risk
• Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
• Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
• Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within <14 days.
• Participants with prior radiotherapy within 2 weeks of start of study therapy.
• Participants with prior allogeneic transplant are prohibited.
• Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
• Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
• Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
• Participants with >=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
• Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug.
• Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment.
• Participants with 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.
• Participants with Known HIV infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load<400 copies/mL b) CD4+ T-cell (CD4+) counts >= 350 cells/microliter (µL) c) No history of AIDS-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only.
• For patients receiving nirogacestat, HIV drugs that are strong CYP3A4 inhibitors are prohibited. HIV drugs that are moderate CYP3A4 inhibitors, while permitted, should be co-administered with caution and must be accompanied by nirogacestat dose modifications.
• Additional Exclusion Criteria for Sub-study 1 and Sub-study 2:
• Participants with autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years.
• Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis.
• Additional Exclusion Criteria for Sub-study 3, 6 and 7:
• Participants with uncontrolled small and/or large intestinal disease.
• Participants with uncontrolled skin disease.
• Participants with any condition causing hypophosphatemia, hypokalemia or hypomagnesemia which is refractory to electrolyte replacement.
• Participants with previous administration of a gamma secretase inhibitor.
• Participants with concomitant administration of a strong CYP3A4 inhibitor or inducer.

Where it is running

• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Grand Rapids, Michigan, United States
• GSK Investigational Site — Madison, Wisconsin, United States
• GSK Investigational Site — Porto Alegre, Brazil
• GSK Investigational Site — Salvador, Brazil
• GSK Investigational Site — São Paulo, Brazil
• GSK Investigational Site — Vancouver, British Columbia, Canada
• GSK Investigational Site — Halifax, Nova Scotia, Canada
• GSK Investigational Site — Toronto, Ontario, Canada
• GSK Investigational Site — Lille, France
• GSK Investigational Site — Villejuif, France
• GSK Investigational Site — Frankfurt, Germany
• GSK Investigational Site — Hamburg, Germany
• GSK Investigational Site — Kiel, Germany
• GSK Investigational Site — Leipzig, Germany
• GSK Investigational Site — Athens, Greece
• GSK Investigational Site — Mexico City, Mexico
• GSK Investigational Site — Leeuwarden, Netherlands
• GSK Investigational Site — Utrecht, Netherlands
• GSK Investigational Site — Oslo, Norway
• GSK Investigational Site — Gdansk, Poland
• GSK Investigational Site — Katowice, Poland
• GSK Investigational Site — Lodz, Poland

Full record on ClinicalTrials.gov

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