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Multiple MyelomaEarly Phase 1CC-220NCT05560399

A Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

A Early Phase 1 study testing Iberdomide, Elotuzumab and Dexamethasone in people with Multiple Myeloma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-arm, open-label study evaluating the safety, tolerability and efficacy of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in patients with RRMM. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Iberdomide, Elotuzumab and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
6 Feb 2023to Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • All subjects must have documented diagnosis of MM with disease progression per IMWG criteria during or after their last anti-myeloma therapy (Appendix D).
  • All subjects must have measurable disease at screening, defined as one or more of the following:
  • Serum IgG, IgA, IgM M-protein ≥ 0.5 g/dL
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  • Urinary M-Protein ≥ 200 mg urinary M-protein excretion in a 24-hour collection sample
  • Involved serum free light chain (sFLC) ≥ 10 mg/dL provided the FLC ratio is abnormal.
  • All patients must have ECOG Performance Status ≤ 2 (Appendix A).
  • Subjects must have received at least 1 and at most 3 lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy) including at least one IMiD (thalidomide, lenalidomide, pomalidomide), a proteosome inhibitor (bortezomib, carfilzomib, ixazomib), and an anti-CD38 agent (daratumumab, isatuximab).
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy tests (minimum sensitivity 25 IU/L or equivalent units of HCG), at 10-14 days prior to start of study drug; another within 24 hours prior to the start of study drug.
  • Women must not be breastfeeding
  • WOCBP must agree to follow instructions for method(s) of contraception for 1 month (4 weeks) before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 5 months post-treatment completion. This includes 2 methods of reliable birth control simultaneously:
  • one highly effective form of contraception - tubal ligation, IUD, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and;
  • additional effective contraceptive method - male latex or synthetic condom, diaphragm, or cervical cap. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy.
  • Males who are sexually active with WOCBP must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Iberdomide (CC-220) and for up to 90 days after discontinuing Iberdomide (CC-220), even if they have undergone a successful vasectomy. Male patients must not donate sperm.
  • Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.
  • All subjects must agree not to share study medication.
  • Male subjects receiving Elotuzumab must agree to follow instructions for method(s) of contraception for 1 month (4 weeks) before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 7 months post treatment completion.
  • Subjects must be willing to refrain from blood donations during study drug therapy and for 90 days after therapy.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia.
  • Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Subjects with active plasma cell leukemia (defined as either 20% of peripheral blood white blood cell count comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L)
  • Subjects with Central Nervous System involvement with multiple myeloma
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
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  • Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk
  • Active infection that requires parenteral anti-infective treatment >14 days
  • Unable to tolerate thromboembolic prophylaxis while on the study
  • Severe hypersensitivity reaction to prior IMiD (thalidomide, lenalidomide or pomalidomide)
  • Grade > 2 peripheral neuropathy (per NCI CTCAE v5.0)
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
  • Known HIV infection or known acquired immunodeficiency syndrome (AIDS).
  • Prior or concurrent malignancy, except for the following:
  • Adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma.
  • Any other cancer from which the subject has been disease free for > 3 years prior to study entry.
  • Prior treatment with Iberdomide (CC-220)
  • Prior treatment with Elotuzumab
  • Use of any anti-myeloma drug therapy within 14 days of the initiation of study drug treatment or use of any experimental drug therapy within 28 days of the initiation of study drug treatment
  • Treatment with melphalan within 4 weeks of the first dose of study drug
  • Treatment with corticosteroids (other than the Dexamethasone of anti-myeloma regimens) within 3 weeks of the first dose of study drug, except for the equivalent of ≤ 10 mg prednisone per day or corticosteroids with minimal to no systemic absorption (i.e., topical or inhaled corticosteroids)
  • Prior autologous stem cell transplant within 12 weeks of the first dose of study drug
  • Prior allogeneic stem cell transplant except subjects who have completed the stem cell transplant > 12 months prior to first dose of study drug, have no history of graft versus host disease, and are not on systemic immunosuppressive therapy
  • Major cardiac surgery within 8 weeks prior to the first dose of study drug; all other major surgery within 4 weeks prior to the first dose of study drug.
  • Subjects with following physical and laboratory test findings:
  • Absolute neutrophil count < 1 x 109/L without growth factor support within 1 week
  • Platelets < 75 x 109/L without transfusion support within 3 days for the dose escalation phase. For the DEC: platelets < 75 x 109/L or < 30 x 109/L if ≥ 50% of bone marrow nucleated cells were plasma cells without transfusion support within 3 days
  • Hemoglobin < 8 g/dL without transfusion support within 3 days of screening
  • Creatinine clearance < 30 ml/min according to the Cockroft-Gault formula:
  • Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dl]
  • Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dl]
  • Total bilirubin ≥ 2 x ULN (≥ 3 x ULN if documented Gilbert's syndrome)
  • AST or ALT ≥ 3x ULN
  • Corrected serum calcium > 13.5 mg/dL
  • Subjects with known severe hypersensitivity or anaphylaxis to Dexamethasone, any excipients in Elotuzumab, formulation or recombinant protein, or any monoclonal antibody
  • Use of strong CYP3A inhibitors within 2 weeks or 5 half-lives of the drug whichever is shorter prior to the first dose of study drug during the dose escalation portion of the study. (In the dose expansion part, strong CYP3A inhibitors may be allowed with appropriate dose adjustments based on the results of the itraconazole drug-drug interaction study. The concomitant use of strong CYP3A induces should be avoided.)
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine

    New York, New York, 10029

Other trials in United States

About this study

Official title: A Multicenter Phase 1-DEC (Dose Expansion Cohort) Open-label Study of Iberdomide (CC-220) in Combination With Elotuzumab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

This is a single-arm, open-label study evaluating the safety, tolerability and efficacy of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in patients with RRMM. The researchers hypothesize that the combination of Iberdomide and Elotuzumab will synergize to promote myeloma cell death, resulting in an overall response rate of at least 53%, with an acceptable safety profile. Patients will be enrolled in a 3+3 dose escalation cohort to evaluate the safety of this combination and to establish the MTD (maximum tolerated dose). The MTD will be the dose for the patients enrolled in dose expansion cohort. A total maximum of 37 patients will be recruited: maximum 18 patients will be recruited in the dose escalation phase, followed by an additional 19 patients in the dose expansion cohort for a total of 25 patients treated at the MTD.

Read the detailed description

Part 1 is an open-label, sequential allocation, dose-finding evaluation of the sequential administration of Iberdomide in combination with Elotuzumab and Dexamethasone at their approved doses for patients with relapsed/refractory multiple myeloma. This phase will follow a standard 3+3 design. During this phase, the maximum tolerated dose of Iberdomide in combination with Elotuzumab and Dexamethasone will be determined and recommended for the dose expansion cohort.

Part 2 of this study is an open-label, single-arm dose expansion cohort that will enroll additional patients at the recommended maximum tolerated dose of Iberdomide as determined in Part 1. Researchers will continue to verify the safety and tolerability of this combination and examine the anti-myeloma activity of the regimen. In addition to measuring overall response rate, duration of response, and survival data, researchers will explore the effect of this combination on the biology of multiple myeloma and the immune system in order to gain insight into patterns of response that may help predict patient population most-likely to benefit from this treatment in the future.

Being tested
Iberdomide, Elotuzumab, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IberdomideDrug

    Also called CC-220

    Route of administration: oral pill. Schedule: Taken Once daily on days 1-21. Dose: will be tested at 1 mg, 1.3 mg, and 1.6mg. 1mg dose may be reduced to 0.75mg if not tolerated.

  • ElotuzumabDrug

    Route of administration: IV Dose: 10 mg/kg for cycles 1 and 2. 20 mg/kg for cycle 3 and beyond. Schedule: Days 1, 8, 15, and 22 for cycles 1 and 2. Then taken on Day 1 (every 28 days) of each cycle thereafter.

  • DexamethasoneDrug

    Route of administration: Oral pill or IV Dose: 36 mg within 24 hrs of day 1 of each cycle and day 8, 15, and 22 of cycle 1 and 2.

    40 mg on days 8, 15, 22 of cycle 3 and all subsequent cycles. (20 mg for > 75 years old).

    Schedule: On days that Elotuzumab is administered, Dexamethasone to be taken 28mg orally (for ≤75 years old) or 8mg orally (for > 75 years old) between 3 and 24 hours before Elotuzumab plus 8 mg IV between 45 and 90 minutes before Elotuzumab for all patients.

    On days that Elotuzumab is not administered but a dose of Dexamethasone is scheduled (Days 8, 15, and 22 of cycle 3 and all subsequent cycles), 40 mg orally for ≤75 years older and 20 mg for

Study groups in NCT05560399
Study groupRoleWhat they receive
Iberdomide, Elotuzumab and DexamethasoneExperimentalDose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase).
Receives: Drug: Iberdomide; Drug: Elotuzumab; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Iberdomide dose limiting toxicity

    The dose limiting toxicity (DLT) rate at the Maximum Tolerated Dose, defined as the proportion of patients in the safety population of the study that experience at least 1 DLT within the first cycle of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone treated at the maximum tolerated dose (MTD).

    Measured: 28 days

Secondary outcomes (8)

  1. Overall Response Rate (ORR)

    Overall Response Rate (ORR) is defined as the proportion of patients treated at the MTD of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in both phase 1 and DEC phase of the study that achieved best overall response of PR or better (Stringent Complete Response (sCR); Complete Response (CR); Very good partial response (VGPR); Partial Response (PR), according to International Myeloma Working Group (IMWG) criteria at Cycle 4 Day 1 (C4D1).

    Measured: up to 3 months

  2. Number of adverse events (AE)

    Number of Adverse Events (AE) - an AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

    Measured: up to 3 months

  3. Progression-free survival (PFS)

    PFS: is defined as the duration of time from start of treatment to the first occurrence of disease progression or death on study from any cause, whichever occurs earlier

    Measured: up to 3 months

  4. Best Overall Response Rate (BOR)

    Best Overall Response Rate (BOR) is defined as the proportion of patients treated at the MTD of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in both phase 1 and DEC phase of the study that achieved sCR, CR, VGPR, PR, minimal response, and Stable Disease (SD), according to IMWG criteria at any evaluation assessment prior to progression of disease as their best response.

    Measured: up to 3 months

  5. Duration of Response (DOR)

    Duration of Response (DOR) is defined as the time from achieving a PR or better to progression, per 2016 IMWG criteria

    Measured: up to 3 months

  6. Overall Survival (OS)

    Overall survival is defined from time from initiation of treatment to death by any cause

    Measured: up to 3 months

  7. Clinical Benefit Rate

    Clinical Benefit Rate is the proportion of patients treated at the MTD of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in both phase 1 and DEC phase of the study that achieved best overall response of minimal response or better (sCR + CR + VGPR + PR + minimal response [MR]) according to the IMWG criteria at C4D1

    Measured: up to 3 months

  8. Disease Control Rate

    Disease Control Rate is the proportion of patients treated at the MTD of Iberdomide (CC-220) in combination with Elotuzumab and Dexamethasone in both phase 1 and DEC phase of the study that achieved best overall response of stable disease or better (sCR + CR + VGPR + PR + MR + SD) according to the IMWG criteria at C4D1

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start6 Feb 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Part 1 is a dose-finding evaluation of Iberdomide in combination with Elotuzumab and Dexamethasone at their approved doses for patients with relapsed/refractory multiple myeloma. Part 2 of this study is an open-label, single-arm dose expansion cohort that will enroll additional patients at the recommended maximum tolerated dose of Iberdomide as determined in Part 1.
Masking
None (open label)
Enrolment
7 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05560399
Sponsor's protocol ID
GCO 22-0016
Acronym
CC-220
Status last verified
Dec 2025
First submitted
26 Sep 2022
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: These data must be collected and processed with adequate precautions to ensure confidentiality and compliance with applicable data privacy protection laws and regulations.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Iberdomide, Elotuzumab and Dexamethasone in people with Multiple Myeloma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Iberdomide dose limiting toxicity (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05560399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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