Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 5)

  • STATUS
    Recruiting
  • End date
    Feb 23, 2028
  • participants needed
    464
  • sponsor
    GlaxoSmithKline
Updated on 26 September 2021
cancer
monoclonal antibodies
measurable disease
tumor cells
monoclonal protein
proteasome inhibitor
refractory multiple myeloma
immunomodulatory imide drug
bcma

Summary

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Isatuximab, GSK3174998, GSK3359609, GSK'916 (belantamab mafodotin), Belantamab mafodotin, dostarlimab, Nirogacestat, feladilimab
Clinical Study IdentifierNCT04126200
SponsorGlaxoSmithKline
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 immunodilating 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)

Exclusion Criteria

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
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
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 or moderate CYP3A4 inhibitor or inducer
Additional Exclusion Criteria for Sub-study 4
Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
Participants who have received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2) agent
Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed
Additional Exclusion Criteria for Sub-study 5
Participants with Severe hypersensitivity to Isatuximab-irfc or to any of its excipients
Participants with prior treatment with other anti-CD38 monoclonal antibody within 6 months of the first dose of study drug treatment
Participants with known intolerance or hypersensitivity to infused proteins products, sucrose, histidine, and polysorbate 80
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