This research study is testing the efficacy of an experimental drug combination for people with newly diagnosed multiple myeloma that are eligible for a stem cell transplant.
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.
Enrollment: 50 patients (estimated)View More
December 11, 2022
Fifty patients enrolled between August 2020 and February 2022. Median age at study entry was 59 years (range 39-70) and 27 (54%) were male. Twenty-three (46%) of patients had high-risk cytogenetics, 6 (12%) were ISS III, and 2 (4%) were R-ISS III. Median follow up was 10.8 months. Of the 47 patients evaluable for response after 4 cycles, the ORR was 100% and 89% (42/47) achieved a very good partial response (VGPR) or better and 40% (19/47) a CR. Of the 47 patients evaluable for response, MRD results were available after C4 for 28 patients achieving a VGPR or better. Of those, 43% (12/28) were MRD negative at 10-5 and 32% (9/28) at 10-6. The 12-month PFS and OS were 97.9% (95% CI 86.1% -99.7%). Most common grade 3 or 4 side effects (≥2 patients) were neutropenia (24%), elevated alanine aminotransferase (10%), acute kidney injury (6%), and thrombocytopenia (6%). Grade 1-2 infusion-related reactions were seen in 20%, no grade 3. Grade 1-2 hypertension was seen in 48% with one grade 3. There was one death assessed as unrelated. Two patients were removed from study for acute kidney injury.
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