Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide

Sponsor
PETHEMA Foundation
Study ID
NCT05060627
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Relapsed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab mafodotin — DRUG
    In phase 1: * Dose level -1: Belantamab-Mafodotin 1.9 mg/kg day 1, Q8W * Dose level 1,2,3: Belantamab-Mafodotin 2.5 mg/kg day 1, Q8W In phase 2: maximum tolerated dose (MTD) of the combination
  • Carfilzomib — DRUG
    In phase 1: * Dose level -1, 1: Carfilzomib 20/45 mg/m2 days 1, 8, and 15, Q4W. * Dose level 2: Carfilzomib 20/56 mg/m2 on days 1, 8, and 15, Q4W * Dose level 3: Carfilzomib 20/70 mg/m2 on days 1, 8, and 15, Q4W. In phase 2: maximum tolerated dose (MTD) of the combination
  • Dexamethasone — DRUG
    Description: Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients \> 75 years old., Q4W

Study Details

This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Since this is the first time that this combination is being evaluated in a clinical trial, a first dose escalation part will be developed following the classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase will be open to recruit up to 60 patients. Patients will receive treatment with belantamab-mafodotin + Kd, until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study, or death.

Key Dates

Start date
Dec 20, 2021
Status verified
May 2026
Primary completion
Oct 23, 2024
Completion
May 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Belantamab-Mafodotin + Carfilzomib+ dexametasona
    In the phase 1 of the study, aiming to establish the recommended phase 2 dose (RP2D), patients will be included following the classic 3 + 3 design. Once the DLT assessment period is completed and the MTD is defined, the recruitment will continue in the expansion phase 2. Combination treatment will be administered at the recommended Phase 2 dose (RP2D) based on the results of the phase 1 dose escalation part of the study: * Belantamab mafodotin on day 1 at the RP2D, every 8 weeks, intravenously (IV). * Carfilzomib will be given at the RP2D weekly IV on days: 1, 8, and 15 of every 4-week cycle (Q4W). * Dexamethasone will be given at the dose of 40 mg (or 20 mg if patient \> 75 years old) on days: 1, 8, 15 and 22 Q4W. From month 13 onwards carfilzomib treatment will be given on day 1 and 15 of every 4-weeks cycles. Belantamab will be given at the RP2D every 8 weeks and Dexamethasone 40mg on days 1, 8, and 15 of every 4-week cycle.

Primary Outcome Measure

Number of participants with adverse events (AEs) during the triplet-therapy in phase I. [ Time Frame: At the end of the first 4-week cycle following a 3+3 design. ]

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