Patients are searching for this trial right now

This page is already ranking on Google. Activate it to start receiving pre-qualified patient leads directly in your inbox.

14-day free trial · $44/mo after · Cancel anytime · Money-back guarantee

NCT06518551 · Omar Nadeem, MD

Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM

What this study is about

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

View original scientific description

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.

Interventions

DRUG

Elotuzumab

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

DRUG

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.

DRUG

Dexamethasone

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

Primary outcome measures

Number of Participants Experiencing Dose Limiting Toxicity (DLT)

Time frame: Up to 4 weeks

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

Maximum Tolerated Dose (MTD)

Time frame: Up to 4 weeks

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

Where

  • Boston, Massachusetts

Collaborators

Celgene, Bristol-Myers Squibb

Related conditions & keywords

MyelomaMultiple MyelomaRefractory Multiple MyelomaRelapsed Multiple MyelomaRelapsed and Refractory Multiple MyelomaMM

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations

📊
1 of 49 participants interested
2% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

NOT_YET_RECRUITING

Boston

Massachusetts

Location available
RECRUITING

Boston

Massachusetts

Location available
RECRUITING

Boston

Massachusetts

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Multiple Myeloma Trials by City

Browse all multiple myeloma clinical trials in these cities — not just this study.

Browse More Trials by Condition

Looking for Multiple Myeloma Treatment in Boston?

Join others in Massachusetts exploring innovative treatment options through clinical research

Multiple Myeloma Treatment Options in Boston, Massachusetts

If you're searching for Multiple Myeloma treatment in Boston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Boston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Multiple Myeloma. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Massachusetts
Now Enrolling
Up to 49 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Multiple Myeloma?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Multiple Myeloma

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Multiple Myeloma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06518551. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.