This research study is being done to learn if the study drug belantamab mafodotin, in combination with other standard medications, can improve multiple myeloma.
This trial is currently open and accepting patients.
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.
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:
Refrain from donating sperm
PLUS either:
INCLUSION CRITERIA - Phase I treatment for Relapsed or Relapsed/Refractory MM:
Subjects with Relapsed or Relapsed/Refractory MM who have had 1-3 lines of prior therapy.
EXCLUSION CRITERIA for all subjects:
Phase 1/2
Enrollment: 70 patients (estimated)
View MoreDecember 09, 2024
Results: With a data cutoff of June 10, 2024, 26 pts consented to phase 1, and 19 were enrolled; 6 pts at 1.4 mg/kg and 13 at 1.9 mg/kg (6 DLT evaluable pts in 1.4 mg/kg cohort and 12 DLT evaluable pts in the 1.9 mg/kg cohort). Median age was 63. Most pts were males 63%, 42% were black, and 53% had high-risk cytogenetics, including 1q gain and 1p deletion. 50% of pts with available ISS staging data at diagnosis had stage III, 42% were refractory to lenalidomide, 11% were bortezomib refractory, 26% were double refractory, and 26% were daratumumab refractory. The median lines of prior therapy was 1 (range 1- 3).
At the 1.4 mg/kg dose level, one DLT of grade 4 thrombocytopenia was reported out of 6 pts. No DLTs were reported among the 12 DLT evaluable pts enrolled at the 1.9 mg/kg dose level (6 pts as part of the dose escalation portion and 6 pts for dose expansion).
The most common adverse events were non-specified eye disorders (total; ≥G3) (94.7%; 31.6%), blurred vision (89.5%; 36.8%), fatigue (57.9%; 0%), hypokalemia (52.6%; 10.5%), cough (47.4%; 0%), diarrhea (47.4%; 0%), and pain (47.4%; 0%).
15 pts experienced G2(+) corneal events per KVA (26 total G2(+) events), and 15 pts experienced a decline of 2 or more lines on the Snellen Visual Acuity scale (25 events). After a median follow-up (IQR) of 16.1 months (11.4; 24.1), 3 pts progressed. The total and median number of cycles of belantamab were 73 and 5 cycles, respectively. All pts achieved a best response of at least a PR, the VGPR(+) rate was 73.7%, and the CR(+) rate was 52.6%, including 52.6% and 36.8% with MRD negativity 10^-5 and 10^-6 by flow cytometry, respectively. Out of 7 pts with R-ISS-III, 57.1% achieved VGPR(+). Out of 8 pts with IMWG high risk cytogenetics, 5 pts (62.5%) achieved a VGPR or better. Responses are expected to deepen with further follow-up. In total, 9 pts achieved sCR, which exceeds the protocol-directed criterion to proceed to Phase 2 at the RPD2 dose. 13 pts are off treatment due to consent withdrawal (n=4), investigator decision post 18 cycles (n=4), participant non-compliance (n=1), and toxicity (n=1).
Conclusions: This phase 1 trial established the MTD of belantamab of 1.9 mg/kg every 8 weeks in combination with KRd. KRd-B is effective even in pts with high-risk MM. Despite the dosing schedule of every 8 week Belamaf dosing, clinically significant keratopathy was common. Pts with high-risk newly diagnosed MM will be enrolled in the phase 2 portion of this trial.
View all clinical trial locations sorted by state.
Winston-Salem, NC
Charlotte, NC
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