This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts:
Dose escalation (Part 1)
Expansion of the Recommended Phase 2 dose (RP2D) (Part 2)
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: 449 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.
View all clinical trial locations sorted by state.
If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.
You can explore trial locations from around the US and connect directly with a trial coordinator.Find Nearby Locations
You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.
Still need help? Send us a message
SparkCures is working closely with Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb to provide the most up-to-date information on this clinical trial. Use the button above to add this trial to your list of favorites.
Learn more about how we work with trial sponsors