Multiple Myeloma Support + Trials

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)

CC-220 monotherapy,
CC-220 in combination with Dexamethasone,
CC-220 in combination with Dexamethasone and Daratumumab,
CC-220 in combination with Dexamethasone and Bortezomib and
CC-220 in combination with Dexamethasone and Carfilzomib;

Expansion of the Recommended Phase 2 dose (RP2D) (Part 2)

CC-220 in combination with Dexamethasone for Relapsed Refractory Multiple Myeloma and
CC-220 in combination with Dexamethasone and Bortezomib 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: 449 patients (estimated)

Need Help?

Interested in joining or learning more about this trial?

(888) 828-2206

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.

Interested in this trial?

Call us today 😀

We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.
(888) 828-2206

Add this trial to your favorites

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.

Find a nearby location

You can explore trial locations from around the US and connect directly with a trial coordinator.
Find Nearby Locations

Talk to your doctor

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

What's the purpose of this trial?

What will happen during the trial?

You may be able to join this trial if you:

Additional Trial Information

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

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

Trial Locations

All Trial Locations

Arizona

Open and Accepting

Not Yet Accepting

Arkansas

Open and Accepting

Georgia

Open and Accepting

Illinois

Open and Accepting

Not Yet Accepting

Open and Accepting

Kansas

Open and Accepting

Maryland

Not Yet Accepting

Open and Accepting

Massachusetts

Open and Accepting

Open and Accepting

Open and Accepting

Michigan

Open and Accepting

Open and Accepting

Nebraska

Open and Accepting

New Jersey

Open and Accepting

New York

Open and Accepting

Open and Accepting

Open and Accepting

Open and Accepting

Open and Accepting

Open and Accepting

North Carolina

Open and Accepting

Ohio

Open and Accepting

Open and Accepting

Pennsylvania

Open and Accepting

South Carolina

Open and Accepting

Tennessee

Not Yet Accepting

Texas

Open and Accepting

Utah

Open and Accepting

Washington

Not Yet Accepting

Not Yet Accepting