TAlquetamab and BeLantamab Mafodotin in Relapsed/Refractory Multiple Myeloma (TaBleMM)

Sponsor
Montefiore Medical Center
Study ID
NCT07720843
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Refractory Multiple Myeloma
  • Relapse Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Talquetamab — DRUG
    Talquetamab dosed at 0.4mg/kg or 0.8mg/kg every 2 weeks
  • Belantamab mafodotin — DRUG
    Belantamab mafodotin dosed at 1.4mg/kg or 1.9 mg/kg every 8 weeks
  • Pomalidomide — DRUG
    Pomalidomide dosed at 4mg Day 1- 21 of 28 day cycles

Study Details

This is a Phase 1, open-label dose escalation study evaluating the safety and clinical efficacy of Talquetamab in combination with Belantamab mafodotin for a time-limited interval followed by Belantamab mafodotin and Pomalidomide maintenance. The study will enroll subjects with Multiple Myeloma that have previously been treated with at least one prior line of therapy and have been treated with IMiDs, proteasome inhibitors, and anti-CD38 therapies either in combination or as single agent and are relapsed or are refractory to, or intolerant of, established therapies with clinical benefit in Multiple Myeloma. Talquetamab will be administered with step up dosing on day 1, 3, 5 with or without day 7 pending target dose (TD1) of Talquetamab (Tal) in dose level. Two weeks after TD1, patients will enroll on C1D1 of Tal (TD2) with Belantamab (Bela). Tal will subsequently be dosed every two weeks. Bela will be administered every 8 weeks on D1 of odd numbered cycles or until resolution of any ocular toxicities to grade 1 or better. After 6 cycles of induction, patients may transition to Bela/Pom maintenance.

Key Dates

First listed
Jul 22, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2032

Study Design

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

Arms

  • Experimental: Talquetamab with Belantamab Dose Escalation and Expansion
    Dose Level 1- Talquetamab 0.4mg/kg q2weeks Belantamab Mafodotin 1.4mg/kg q8weeks Dose Level 2A- Talquetamab 0.8mg/kg q2weeks Belantamab Mafodotin 1.4mg/kg q8weeks Dose Level 2B- Talquetamab 0.4mg/kg q2weeks Belantamab Mafodotin 1.9mg/kg q8weeks Dose Level 3- Talquetamab 0.8mg/kg q2weeks Belantamab Mafodotin 1.9mg/kg q8weeks Talquetamab will be administered with step up dosing on day 1, 3, 5 with or without day 7 (dependent on target dose level of 0.4mg/kg or 0.8mg/kg) of Talquetamab. Two weeks after TD1, participants will enroll on C1D1 of Tal (TD2) with Belantamab. Tal will subsequently be dosed every two weeks. Belantamab will be administered every 8 weeks on D1 of odd numbered cycles or until resolution of any ocular toxicities to Grade 1 or better. After 6 cycles of induction, participants may transition to Bela/Pom maintenance. Patients who maintain MRD negativity for at least 1 year may also hold treatment.

Primary Outcome Measure

Frequency and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Through the first 28 days of treatment ]

Central Contacts

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