This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed 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.
Other protocol-defined inclusion/exclusion criteria apply
Enrollment: 532 patients (estimated)View More
December 11, 2021
As of June 2, 2021, 107 pts had received IBER + DEX. Median age was 64 (44–83) years; median time since initial diagnosis was 6.9 (1.6–24.5) years. Extramedullary plasmacytomas were present in 25.2% of pts; 29.9% of pts had high-risk cytogenetics. Median number of prior regimens was 6 (3–23). All pts were triple-class exposed; prior therapies included autologous stem cell transplantation (78.5%), PIs (100%), IMiD agents (LEN [100%] and POM [100%]), and anti-CD38 mAbs (100%); 99.1% of pts were refractory to last myeloma regimen and 97.2% of pts were triple-class refractory. Median follow-up was 7.69 (0.5–17.5) months, with a median number of 4 (1–17) cycles received and 13 (12.1%) pts continuing treatment. Main reason for discontinuation was progressive disease (69.2%).
ORR was 26.2%, with 1 (0.9%) stringent complete response, 8 (7.5%) very good partial responses, and 19 (17.8%) partial responses (Table); the clinical benefit rate (≥ minimal response) was 36.4% and disease control rate (≥ stable disease) was 79.4%. Median duration of response was 7.0 (4.5–11.3) months (Table), median progression-free survival was 3.0 (2.8–3.7) months, and median overall survival was 11.2 (9.0–not reached) months. Similar response rates were observed among a cohort of pts also exposed to BCMA therapies (N = 24, Table).
Grade (Gr) 3–4 treatment-emergent adverse events (TEAEs) were reported in 88 (82.2%) pts. Most frequent (≥ 20% pts) hematologic Gr 3–4 TEAEs were neutropenia (44.9%; and 4.7% febrile neutropenia), anemia (28.0%), thrombocytopenia (21.5%), and leukopenia (20.6%). Gr 3–4 infections were reported in 27.1% of pts; Gr 3–4 pneumonia and COVID-19 occurred in 10.3% and 4.7% of pts, respectively. Occurrence of other Gr 3–4 non-hematologic TEAEs was generally low, including gastrointestinal disorders (5.6%), fatigue (2.8%), rash (1.9%). Fifty-six (52.3%) pts and 20 (18.7%) had IBER dose interruptions and reductions due to TEAEs, respectively. Five (4.7%) pts discontinued due to TEAEs. No pt discontinued IBER due to neutropenia.
September 10, 2021
In the phase 1 CC-220-MM-001 (NCT02773030) trial, researchers evaluated the safety and efficacy of iberdomide. Lonial shared data for cohorts E, F, and G, as data for cohorts A and B (single-agent iberdomide and iberdomide plus dexamethasone, respectively) are not yet available. Cohorts E, F, and G received iberdomide plus dexamethasone in combination with daratumumab (IberDd; n = 43), bortezomib (IberVdl; n = 25), and carfilzomib (IberKd; n = 9), respectively.
In terms of the safety profile, notable hematologic grade 3-4 treatment-emergent adverse events (TEAEs) were neutropenia (67%), leukopenia (23%), anemia (21%), and febrile neutropenia (5%) within the IberDd cohort; neutropenia (28%) and thrombocytopenia (24%) in the IberVd cohort; and lymphopenia (44%) and neutropenia (33%) for patients receiving IberKd. Non-hematologic TEAEs were few, with several patients experiencing grade 3-4 fatigue, rash, and gastrointestinal disorders.
Overall response rate was 46% in patients receiving IbderDd, 56% in IberVd, and 50% in IberKd. There was a very good partial response or better in 24%, 28%, and 38% of patients within the 3 cohorts, respectively.
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