This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible multiple myeloma
This trial is currently open and accepting patients.
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.
As part of a dose escalation phase, the first 10 patients will be enrolled at dose level -1 (Iberdomide 1.1 mg po daily days 1-21). Two months after the first 10 patients have completed at least 2 cycles of therapy in dose level -1, an Independent Safety Review Committee will review the safety data. Assuming the combination is determined to have adequate safety and tolerability, 10 patients will be enrolled at dose level 1 (Iberdomide 1.3 mg po daily days 1-21). After an independent safety review two months after 10 patients have completed at least 2 cycles of therapy in dose level 1, the remaining 46 patients will be enrolled at dose level 2 (Iberdomide 1.6 mg po daily days 1-21).
Treatment will continue for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until disease progression or the start of a new line of therapy.
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 1/2
Enrollment: 66 patients (estimated)
View MoreDecember 09, 2023
At data cutoff (July 14, 2023), there were 13 patients enrolled, which included 11 and 2 patients enrolled in the phase 1 and 2 studies, respectively. Ten patients are on trial, 2 were screen failures, and 1 is in screening. Of the 10 patients on trial, the median age was 66 years (range 46-78), 40% male, 70% white, and 30% had ISS stage II MM. Four unique patients had high-risk cytogenetics, which included 2 patients with t(4;14), 2 with 1q21 duplication, 1 with t(14;16), 1 with del(17p)/monosomy 17, and 1 with TP53 mutation.
In the phase 1 study, 3 patients enrolled at the starting dose level of iberdomide 1 mg. Grade 1-2 TEAEs occurred in all 3 patients, but no DLTs occurred. The next 3 patients were enrolled at the iberdomide dose of 1.3 mg. Grade 1-2 TEAEs occurred in 2 patients (rash and pruritus), but no grade ≥3 TEAEs were observed. Three patients were enrolled into the final dose level of iberdomide 1.6 mg. Grade 1-2 TEAEs occurred in 2 patients, and 2 patients experienced grade 3 TEAEs (rash and neutropenia). As no DLTs occurred, the MTD of iberdomide was determined to be 1.6 mg given in combination with CFZ and DEX.
Patients on trial (n=10; 6 in follow-up and 4 actively receiving treatment) have completed a median of 3 (range 2-4) cycles of KID. Of these patients, 7/10 experienced TEAEs (Table 1). No treatment-related deaths occurred. The most common TEAEs were maculopapular rash (46%), elevated liver function tests (38%), gastrointestinal symptoms (31%), and neutropenia (23%). Grade 3 TEAEs occurred in 2 patients (rash and neutropenia). One patient experienced a SAE of erythema multiforme on two separate occurrences (grade 1 and grade 2), which resolved with drug interruption. In 9 patients with response data available, the best ORR was 100% (CR, 1 [12%]; very good partial response [VGPR], 4 [44%]; partial response [PR], 4 [44%]). Six patients proceeded to ASCT with a median amount of stem cells mobilized of 9.42 x 106 cells/kg (range 4.84-13.53). At 3-months post-ASCT, the ORR was 100% (CR, 3 [50%]; VGPR, 2 [33%]; PR, 1 [17%]). One patient had documented sCR and MRD-negativity at data cutoff. Median PFS was not reached (NR) (95% CI, NR-NR).
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Hackensack, NJ
Washington, DC
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