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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Male or Female subjects > 18 years of age

Be willing and able to provide written informed consent prior to any protocol-related procedures including screening evaluations.

Must meet 2014 International Myeloma Working Group (IMWG) guideline for diagnosis of Multiple Myeloma (and not smouldering myeloma) Dose Escalation: Participants in dose escalation must have measurable disease as defined by IMWG criteria, or have active bone findings on PET/CT or >1 measurable plasmacytoma that can be monitored on other imaging modalities.

Dose Expansion: Participants must have measurable disease by IMWG criteria.

Disqualifiers

Amyloidosis

Plasma Cell Leukemia

POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

Myelodysplastic Syndrome, Myeloproliferative Neoplasia, or any other primary hematologic malignancy concurrent with Multiple Myeloma

Trial design

Treatments tested in this trial

  • Talquetamab
  • Belantamab mafodotin
  • Pomalidomide

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Montefiore Medical Center

Lead sponsor

GlaxoSmithKline

Collaborator