Recruiting

Phase 1

Phase 2

Elotuzumab, Iberdomide, DexamethasoneElotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM

Sponsor:

Omar Nadeem, MD

Code:

NCT06518551

Conditions

Myeloma

Multiple Myeloma

Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elotuzumab

Iberdomide

Dexamethasone

Study Details

Brief summary:

The aim of this research study is to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma.

The names of the study drugs involved in this study are:

Iberdomide (a type of cereblon E3 ligase modulator)
Elotuzumab (a type of monoclonal antibody)
Dexamethasone (a type of steroid)

Conditions

Myeloma

Multiple Myeloma

Refractory Multiple Myeloma

Study ID

NCT06518551

Start date

Nov 1, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2034

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Previously diagnosed with MM based on standard IMWG criteria
Patient has given voluntary written informed consent before any study-related procedures not part of normal medical care are performed, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Patient who has been treated with at least 4 prior lines of anti-myeloma treatment including immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
In addition, to at least 4 prior lines of anti-myeloma treatment, patient has received ide-cel in accordance with the FDA approved US Prescribing Information and has achieved at least a partial response, and is within 90 days of infusion
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Screening Laboratory evaluations within the following parameters

Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L) (Growth factors cannot be used more recently than 7 days prior to initiation of therapy)
Platelet count ≥ 75,000 cells/dL (75 x 109/L) (without transfusions during the 7 days prior to initiation of therapy)
Hemoglobin ≥ 8.0 g/dL (RBC transfusions are permitted)
Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
AST or ALT ≤ 3x ULN
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 = \[(140 - age in years) x weight in kg x 1.00\] / \[72 x serum creatinine in mg/dL\]
Age ≥18 years.
Ability to understand and the willingness to sign a written informed consent document.
A Female of childbearing potential (FCBP) must:

Have two negative pregnancy tests before enrollment and randomization into the clinical studies and prior to each re-supply of study drug during the clinical studies based on the frequency outlined in the Pregnancy Prevention Plan (PPP, Appendix D).
Sexually active FCBP must agree to use protocol-specified contraceptive methods during participation in the clinical studies and for at least 28 days after the last dose of study drug.
Sexually active males (including those who have had a vasectomy) must agree to use protocol specified contraceptive methods during participation in the clinical studies and for at least 28 days after the last dose of study drug.
All participants (male and female with or without childbearing potential) must agree to abstain from donating blood products for at least 28 days after the last dose of study drug and semen or sperm while taking study drug and for at least 28 days after the last dose of study drug.

Exclusion Criteria

Prior exposure to Iberdomide
Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy
Known central nervous system involvement.
Systemic treatment, within 14 days before the first dose of treatment, with strong CYP3A or inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort OR systemic treatment within 14 days of the first dose of treatment with a strong inhibitor of CYP1A2 (ciprofloxacin, fluvoxamine, cimetidine, enoxacin, ethynyl estradiol, mexiletine)
Any medical or psychiatric illness/social situation that in the Investigator's opinion, would impose excessive risk to the patient, would adversely affect his/her participating in this study or would limit compliance with study requirements.
Currently active graft versus host disease of any stage or grade after allogeneic stem cell transplantation
Prior major surgical procedure or radiation therapy within 14 days of initiation of therapy.

Those who require a limited course of radiation for management of bone pain more than 14 days out from initiation of therapy are not excluded
Any active, or uncontrolled cardiovascular conditions, including but not limited to uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, grade 3 thromboembolic event or myocardial infarction within the past 6 months.
The following therapies within the stated time frames prior to initiation of therapy:

Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 21 days (42 days for nitrosoureas).
The use of live vaccines within 30 days.
IMiDs or proteasome inhibitors within 14 days.
Other investigational therapies and/or monoclonal antibodies within 4 weeks.
Prior peripheral stem cell transplant within 12 weeks.
Prior allogeneic stem cell transplantation with active graft-versus-host-disease.
Those who require a limited course of daily requirement for corticosteroids (equivalent to >10 mg/day prednisone, though >10mg/day is acceptable if physiological levels require, so long as the dose is stable for at least 7 days prior to initiation of therapy. Inhalation corticosteroids are exempt from this criterion.

Lower amounts of corticosteroids that are not part of a daily requirement within 14 days prior to initiating therapy
Concurrent symptomatic amyloidosis or plasma cell leukemia
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
Infection requiring systemic antibiotic therapy or other serious infection within 7 days of starting therapy.

Those who are on prophylactic antibiotics only, or on antibiotics and have confirmation of resolution of active infection are eligible.
Known seropositive for active viral infection with human immunodeficiency virus (HIV) hepatitis B (HBV) or hepatitis C viral (HCV). Those who are seropositive because of hepatitis B vaccine are eligible. Patients who are positive for HBV core antibody or HBV surface antigen must have a negative polymerase chain reaction (PCR) result prior to enrollment. Those who are PCR positive will be excluded
Female patients who are pregnant or lactating.
Participants who are receiving any other investigational agents for any indication
History of erythema multiforme or severe hypersensitivity to prior IMiD's® or those who have a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
Inability to tolerate thromboprophylaxis
Failure to have fully recovered (≤ Grade 2 according to CTCAE v 5) from the reversible effects of prior chemotherapy

Study Design

Enrollment

49 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1: Dose Escalation

Participants will be enrolled in a standard 3+3 dose escalation design to find the Maximum Tolerated Dose (MTD) of Iberdomide, starting at Dose Level 0 and increasing to Dose Level 1

Baseline visit
Cycle 1 through Cycle 2:

Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily
Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily
Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Elotuzumab 1x daily
Cycle 3 through End of Treatment:

Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily
Day 1 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily
Day 1 of 28 Day Cycle: Predetermined dose of Elotuzumab 1x daily
End of Treatment visit
14 Day Follow Up Visit: to be in-clinic after end of treatment visit
Follow Up: Every 28 days for up to 2 years
Dose expansion will proceed according to dose-limiting toxicity (DLT) guidelines per the protocol

experimental: Phase 2: Dose Expansion

Participants will be enrolled and will complete study procedures as follows:

Baseline visit
Cycle 1 through Cycle 2:

Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily.
Days 1, 8, 15, and 22 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily.
Days 1, 8, 15, and 22 of 23 Day Cycle: Predetermined dose of Elotuzumab 1x daily.
Cycle 3 through End of Treatment:

Days 1 through 21 of 28 Day Cycle: Predetermined dose of Iberdomide 1x daily.
Day 1 of 28 Day Cycle: Predetermined dose of Dexamethasone 1x daily.
Days 1, 8, 15, and 22 of 23 Day Cycle: Predetermined dose of Elotuzumab 1x daily.
End of Treatment visit
14 Day Follow Up Visit: to be in-clinic after end of treatment visit.
Follow Up: Every 28 days for up to 2 years

Interventions

Elotuzumab

Humanized, recombinant IgG1 monoclonal antibody, 400- and 300-mg single-use vials, via intravenous (into the vein) infusion per protocol.

Iberdomide

A cereblon E3 ligase modulator, 0.15mg, 0.2mg, 0.3mg, 0.45mg, 0.6, and 0.75 mg strength capsule taken orally per protocol.

Dexamethasone

Synthetic adrenocortical steroid, 2 and 4 mg tablets, taken orally per standard of care.

Primary outcome measure

Number of Participants Experiencing Dose Limiting Toxicity (DLT) [Phase I] [ Time Frame: Up to 4 weeks ]
Maximum Tolerated Dose (MTD) [Phase I] [ Time Frame: Up to 4 weeks ]
Progression-free Survival Rate at 12 months (rPFS12) [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Omar Nadeem, MD

617-632-4703 Omar_Nadeem@dfci.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

David Avigan, MD

617-667-9920 davigan@bidmc.harvard.edu

Principal Investigator:

David Avigan, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Omar Nadeem, MD

617-632-4703 Omar_Nadeem@dfci.harvard.edu

Principal Investigator:

Omar Nadeem, MD

More Information

Sponsor

Omar Nadeem, MD

Last update posted

Dec 11, 2025

Last verified

Nov, 2025

Keywords

Myeloma
Multiple Myeloma
Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Relapsed and Refractory Multiple Myeloma
MM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Omar Nadeem, MD on 2025-12-11.