This is a phase I dose escalation and expansion study in RMM and RRMM followed by a single arm phase II expansion in high risk, NDMM. The phase I portion of the protocol will utilize a standard 3+3 dose escalation design to determine the maximum tolerated dose (MTD) and RP2D of the KRd-belantamab mafodotin combination. The phase II portion of the trial is a two-stage design that will assess the efficacy and safety of the combination in newly diagnosed, high-risk MM patients.
This trial is currently open and accepting patients.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
INCLUSION CRITERIA for all subjects:
INCLUSION CRITERIA - Phase I treatment for Relapsed or Relapsed/Refractory MM:
INCLUSION CRITERIA - Phase II treatment for high-risk newly diagnosed MM:
1. Active, newly diagnosed multiple myeloma with CRAB features or a myeloma-defining event per the IMWG 2014 criteria. Note: It is acceptable to include subjects who have had one cycle of emergent treatment for multiple myeloma.2. High-risk disease: i. Del(1p) ii. Gain of 1q21 [greater than or equal to 3 copies] iii. Monosomy 13 or del(13q) by conventional karyotype iv. High risk IgH translocation [t(4;14), t(14;16) or t(14;20)] v. del(17p) 3. Measurable disease by 1 or more of the following:
EXCLUSION CRITERIA for all subjects:
Enrollment: 70 patients (estimated)View More
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