The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma.
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:
Exclusion Criteria:
Phase 2
Enrollment: 60 patients (estimated)
View MoreDecember 10, 2023
At the time of data cut off in May 2023, 38 patients have been enrolled to part 1 with a median follow up of 18 months. The median age is 62 years old (range 36-77) with 23 females (61%) and 15 males (39%). The median plasmacytosis of enrolled patients was 20%, with median M-protein of 2.17 g/dL and median FLC ratio of 8.1. Twenty-four patients (62%) had at least one high-risk FISH abnormality (fifteen with 1q gain, four with t(4;14), one with t(14;16) and one with del 17p). Eight patients (21%) had more than one high-risk FISH abnormality.
Most common grade 3 toxicities included neutropenia (13%), ALT increased (8%), and diarrhea (8%). Upper respiratory infections occurred in 61% of patients but were mostly low-grade (COVID-19 infection in 11 patients, 1 with grade 3). No patients discontinued therapy due to toxicity.
Of the 35 patients that completed at least 2 cycles of therapy, the ORR is 100% with 43% CR, 34% VGPR and 17% PR with responses deepening over time. Seventy-seven percent of patients achieved VGPR or greater. MRD was evaluable in 22 patients at 6 months with MRD negativity rate of 59% and 14% at thresholds of 10-5 and 10-6, respectively. At 12 months, 20 patients were MRD-evaluable with 65% and 20% achieving MRD negativity at 10-5and 10-6, respectively. Of the 10 MRD-evaluable patients at 24 months, 60% were MRD negative at 10-5 and 40% at 10-6. No patients have progressed on treatment. Stem cell collection was successful in all eligible patients with average stem cell yield of 5.53 x 106 CD34+ cells/kg.
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