A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma
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What's the purpose of this trial?

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.


What will happen during the trial?

You may be able to join this trial if you:

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:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
  • Relapsed and refractory multiple myeloma (RRMM) participants must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy
  • Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM)
  • Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation

Exclusion Criteria:

  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
  • Nonsecretory multiple myeloma
  • Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years

Other protocol-defined inclusion/exclusion criteria apply


Additional Trial Information

Phase 1/2

Enrollment: 532 patients (estimated)

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Published Results

Iberdomide (IBER) in Combination with Dexamethasone (DEX) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Dose-Expansion Phase of the CC-220-MM-001 Trial

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.

Early Data Indicate Iberdomide Combination Yields a Promising Safety Profile in Relapsed/Refractory Myeloma

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.

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

Arkansas

University of Arkansas for Medical Sciences (UAMS)

Little Rock, AR

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Illinois

Robert H. Lurie Comprehensive Cancer Center Northwestern University

Chicago, IL

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Maryland

Massachusetts

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Massachusetts General Hospital

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, MI

Open and Accepting

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

NYU Winthrop Hospital

Mineola, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

NewYork-Presbyterian/ Weill Cornell Medical Center

New York, NY

Open and Accepting

Weill Cornell

New York, NY

Open and Accepting

University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

Open and Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Ohio

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Pennsylvania

Abramson Cancer Center University of Pennsylvania

Philadelphia, PA

Open and Accepting

South Carolina

Prisma Health Cancer Institute - Grove Commons

Greenville, SC

Open and Accepting

Texas

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting
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