Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM

NCT06518551 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 24-189
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants Experiencing Dose Limiting Toxicity (DLT) [Phase I]

  Toxicities are to be assess according to the CTCAE v5. DLT criteria could be referred as follow: * Grade ≥3 non-hematologic toxicity that cannot be clearly related to disease progression or other circumstances clearly not linked to study treatment. * Grade 4 thrombocytopenia (platelet count \< 25,000 cells/ mm3) on more than one occasion that cannot be attributed to underlying disease * Grade 3 thrombocytopenia with bleeding * Grade 4 neutropenia (ANC \< 500 cells/mm3) lasting for \>7 days * Any Grade 5 event, unless due to progressive disease

  Up to 4 weeks

• Maximum Tolerated Dose (MTD) [Phase I]

  The MTD is defined as the highest dose level where at most 1 participant (of the 6 treated) develops a DLT, and 2 or more of the 3 to 6 participants developed a DLT at the next higher dose level unless the MTD is identified as dose level 1.

  Up to 4 weeks

• Progression-free Survival Rate at 12 months (rPFS12)

  rPFS12 is defined as the proportion fo participants who are alive and progression-free at 12 months after treatment initiation. Participants who have died, progressed, or lost to follow-up prior to the primary assessment visit 12 months after treatment initiation will be counted in the denominator for the primary endpoint.

  Up to 12 months

Secondary Outcomes (7)

• Minimal Residual Disease (MRD) Rate

  Up to 12 months

• Median Time-to-progression (TTP)

  Up to 4 years

• Duration of Response (DOR)

  Up to 4 years

• Duration of Complete Response (DOCR)

  Up to 4 years

• Median Overall Survival (OS)

  Up to 4 years

Study Arms (2)

Phase 1: Dose Escalation

EXPERIMENTAL

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

Drug: Elotuzumab; Drug: Iberdomide; Drug: Dexamethasone

Phase 2: Dose Expansion

EXPERIMENTAL

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

Drug: Elotuzumab; Drug: Iberdomide; Drug: Dexamethasone

Interventions

Elotuzumab DRUG

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

Also known as: BMS-901608

Phase 1: Dose Escalation; Phase 2: Dose Expansion

Iberdomide DRUG

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.

Also known as: CC-220, Iberdomide hydrochloride, C25H28N3O5Cl, BMS-986382

Phase 1: Dose Escalation; Phase 2: Dose Expansion

Dexamethasone DRUG

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

Also known as: Decadron, 9- fluoro11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione

Phase 1: Dose Escalation; Phase 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omar Nadeem, MD: lead
• Celgene: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Multiple Myeloma; Recurrence

Interventions

elotuzumab; iberdomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Omar Nadeem, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Nadeem, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2034
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (3)