Study of Belantamab Mafodotin, Cevostamab, Pomalidomide for RRMM Patients (MAPLE)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCanadian Myeloma Research Group
About this trial
This study will evaluate efficacy and tolerability various doses of belantamab mafodotin in combination with cevostamab and pomalidomide in patients with multiple myeloma who have relapsed disease after two or more lines of therapy and/or have refractory to treatment disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be able to understand and voluntarily sign an informed consent form (ICF).
Must be ≥ 18 years of age at the time of signing the ICF.
Must be able to adhere to the study visit schedule and other protocol requirements.
Lines of therapy are defined as per the consensus panel of the International Myeloma Workshop and include induction therapy followed by ASCT and consolidation/maintenance as one line.
Disqualifiers
Prior treatment with bispecific or BCMA targeted antibody drug conjugate. Note prior anti-BCMA CAR T-cell therapy is permitted provided that the subject achieved a response of partial response (PR) or better and did not progress within 12 months of CAR T-cell infusion.
Prior exposure to FcRH5 targeted therapy.
Life-expectancy less than or equal to 12 weeks.
WOCBP who are pregnant or lactating.
Trial design
Design model
Sequential
Treatments tested in this trial
Belamaf
DrugAdministered intravenously
Cevostamab
Biological/VaccineAdministered intravenously
Pomalidomide
DrugAdministered orally
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Belamaf + CevostamabExperimental treatment 2 interventions
Group B: Belamaf + Cevostamab+ PomalidomideExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Recommended Phase 2 Dose (RP2D)
The Recommended Phase 2 Dose (RP2D) will be determined based on the incidence of dose-limiting toxicities (DLTs), overall tolerability, and preliminary antitumor activity. DLTs will be evaluated based on adverse events, clinical assessments, and laboratory test results.
Time frame
From the first dose of study drugs until the end of 3 cycles of therapy (up to 9 weeks; each cycle is 21 days) in the last dose-escalation cohort, or until study therapy is discontinued due to disease progression or toxicity, whichever occurs first.2
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of participants who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to International Myeloma Working Group (IMWG) criteria.
Time frame
From 3 weeks after the first dose of study therapy (end of Cycle 1; Cycle 1 is 21 days) until the date of documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.Secondary outcomes
1
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
Time frame
From the date of the first dose of study therapy until the date of documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.2
Duration of Response (DOR)
Duration of Response (DOR) is defined as the time from the date of first documented partial response (PR) or better until documented disease progression or death from any cause, whichever occurs first.
Time frame
From the date of first documented partial response or better to the date of documented disease progression or death, whichever occurs first, assessed up to 24 months.3
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study treatment to death from any cause.
Time frame
From the date of the first dose of therapy until the date of death from any cause, assessed up to 24 months.4
Rates of Corneal Adverse Events
The proportion of participants experiencing corneal adverse events, including a decrease in best corrected visual acuity (\>20/50) in both eyes at the same time, at the recommended dose of belamaf in combination with cevostamab.
Time frame
From 1 day before receiving belamaf until the end of treatment or, if corneal findings are present, until corneal findings return to pre-treatment (baseline) condition or become stable, assessed up to 12 months.Sponsors and contacts
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Source ClinicalTrials.gov
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