MyelomaPhase 1NCT06518551
ELEVATE-MM: Elotuzumab, Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
A Phase 1 study testing Elotuzumab, Iberdomide and Dexamethasone in people with Myeloma and Multiple Myeloma, run by Omar Nadeem, MD at 3 sites in United States.
Trial summary
The aim of this research study is to evaluate the safety and tolerability of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma, Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Elotuzumab, Iberdomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2024to 31 Dec 2034
- Phase
- 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
- 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any study-related procedures not part of normal medical care are performed, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Omar Nadeem, MD, 617-632-4703, Omar_Nadeem@dfci.harvard.edu
Omar Nadeem, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
David Avigan, MD, 617-667-9920, davigan@bidmc.harvard.edu
David Avigan, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Omar Nadeem, MD, 617-632-4703, Omar_Nadeem@dfci.harvard.edu
Omar Nadeem, MD
About this study
Official title: A Phase I Study of Elotuzumab and Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
The aim of this research study is to evaluate the safety and tolerability 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)
Read the detailed description
This is a phase I, open-label, non-randomized, single-stage study to evaluate the safety and tolerability of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma. Iberdomide has demonstrated some antitumor activity in laboratory studies.
The U.S. Food and Drug Administration (FDA) has approved Elotuzumab as a treatment option for Multiple Myeloma. Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias. The U.S. Food and Drug Administration (FDA) has not approved Iberdomide as a treatment for Multiple Myeloma.
The research study procedures include screening for eligibility, study treatment visits, bone marrow biopsies, blood and urine tests, electrocardiograms (ECGs), X-rays, and Positron Emission Tomography (PET) scans, Computerized Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans.
It is expected that about up to 24 people will take part in this research study.
Bristol-Myers Squibb and Celgene, a BMS company, are supporting this research study by providing study drug and providing funding for the trial.
- Conditions
- Myeloma, Multiple Myeloma, Refractory Multiple Myeloma
- Being tested
- Elotuzumab, Iberdomide, Dexamethasone
- Keywords
- Myeloma, Multiple Myeloma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed and Refractory Multiple Myeloma, MM
- Medical subject headings
- Neoplasms, Plasma Cell, Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabDrug
Also called BMS-901608
Humanized, recombinant IgG1 monoclonal antibody, 400- and 300-mg single-use vials, via intravenous (into the vein) infusion per protocol.
IberdomideDrug
Also called CC-220, Iberdomide hydrochloride, C25H28N3O5Cl, BMS-986382
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.
DexamethasoneDrug
Also called Decadron, 9- fluoro11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
Synthetic adrenocortical steroid, 2 and 4 mg tablets, taken orally per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Elotuzumab; Drug: Iberdomide; Drug: Dexamethasone |
| Phase 1: 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 Receives: Drug: Elotuzumab; Drug: Iberdomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose Limiting Toxicity (DLT)
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
Measured: Up to 4 weeks
Maximum Tolerated Dose (MTD)
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.
Measured: Up to 4 weeks
Secondary outcomes (8)
Minimal Residual Disease (MRD) Rate
MRD rate is defined as the proportion of participants who still have detectable cancer cells after treatment. IMWG MRD negativity category is listed in protocol section 11.
Measured: Up to 12 months
Median Time-to-progression (TTP)
Median TTP is defined as the time from start of ide-cel treatment to progression or censored at date of last disease evaluation for those without progression reported based on Kaplan-Meier method.
Measured: Up to 4 years
Duration of Response (DOR)
DOR based on Kaplan-Meier methodology is defined as the time from initiation of first response to ide-cel until first documentation of disease progression or death. Participants who have not progressed are censored at the date last known progression-free.
Measured: Up to 4 years
Duration of Complete Response (DOCR)
DOCR based on Kaplan-Meier methodology is defined as the time from initiation of CR after ide-cel therapy to first documentation of disease progression or death. Participants who have not progressed are censored at the date last known progression-free.
Measured: Up to 4 years
Median Overall Survival (OS)
Median OS based on Kaplan-Meier methodology is defined as the time from start of ide-cel treatment to death due to any cause or censored at date last known alive.
Measured: Up to 4 years
Extramedullary disease (EMD) response rate
EMD is defined as the percentage of participants with baseline EMD who achieved partial response or better based on the International Myeloma Working Group Response (IMWG) criteria during treatment.
Measured: Up to 12 months
Grade 3-5 Treatment-Related Toxicity Rate
The percentage of participants who experienced a maximum grade 3-5 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Measured: Up to 4 years
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omar Nadeem, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene, Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Omar Nadeem, MD, Dana-Farber Cancer Institute
- Investigators
- Omar Nadeem, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518551
- Sponsor's protocol ID
- 24-189
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Elotuzumab and Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06518551
- Acronym / sponsor ID
- 24-189
- Conditions
- Myeloma, Multiple Myeloma, Refractory Multiple Myeloma
- Keywords
- Myeloma, Multiple Myeloma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed and Refractory Multiple Myeloma, MM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Omar Nadeem, MDUniversity, hospital or other
- Collaborators
- Celgene, Bristol-Myers Squibb
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research study is to evaluate the safety and tolerability 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)
Detailed description
This is a phase I, open-label, non-randomized, single-stage study to evaluate the safety and tolerability of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma. Iberdomide has demonstrated some antitumor activity in laboratory studies.
The U.S. Food and Drug Administration (FDA) has approved Elotuzumab as a treatment option for Multiple Myeloma. Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias. The U.S. Food and Drug Administration (FDA) has not approved Iberdomide as a treatment for Multiple Myeloma.
The research study procedures include screening for eligibility, study treatment visits, bone marrow biopsies, blood and urine tests, electrocardiograms (ECGs), X-rays, and Positron Emission Tomography (PET) scans, Computerized Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans.
It is expected that about up to 24 people will take part in this research study.
Bristol-Myers Squibb and Celgene, a BMS company, are supporting this research study by providing study drug and providing funding for the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose Escalation | Experimental | Drug: Elotuzumab, Drug: Iberdomide, Drug: DexamethasoneParticipants 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 |
| Phase 1: Dose Expansion | Experimental | Drug: Elotuzumab, Drug: Iberdomide, Drug: DexamethasoneParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (29 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElotuzumabAlso: BMS-901608Humanized, recombinant IgG1 monoclonal antibody, 400- and 300-mg single-use vials, via intravenous (into the vein) infusion per protocol. | Drug | Phase 1: Dose Escalation, Phase 1: Dose Expansion |
| IberdomideAlso: CC-220, Iberdomide hydrochloride, C25H28N3O5Cl, BMS-986382A 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 | Phase 1: Dose Escalation, Phase 1: Dose Expansion |
| DexamethasoneAlso: Decadron, 9- fluoro11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dioneSynthetic adrenocortical steroid, 2 and 4 mg tablets, taken orally per standard of care. | Drug | Phase 1: Dose Escalation, Phase 1: Dose Expansion |
Primary outcome
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.
8 secondary outcomes
Minimal Residual Disease (MRD) Rate
Time frame: Up to 12 months
Median Time-to-progression (TTP)
Time frame: Up to 4 years
Duration of Response (DOR)
Time frame: Up to 4 years
Duration of Complete Response (DOCR)
Time frame: Up to 4 years
Median Overall Survival (OS)
Time frame: Up to 4 years
Extramedullary disease (EMD) response rate
Time frame: Up to 12 months
Grade 3-5 Treatment-Related Toxicity Rate
Time frame: Up to 4 years
Progression-free Survival Rate at 12 months (rPFS12)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar Nadeem, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elotuzumab, Iberdomide and Dexamethasone in people with Myeloma and Multiple Myeloma, run by Omar Nadeem, MD at 3 sites 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 21 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Omar Nadeem, MD (617-632-4703, Omar_Nadeem@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose Limiting Toxicity (DLT) (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.