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Recurrent Multiple MyelomaPhase 1/2NCT06785415

Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma

A Phase 1/2 study testing Bone Marrow Aspiration, Bone Marrow Biopsy and Bone Scan in people with Recurrent Multiple Myeloma, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I/II trial tests the safety, side effects, and best dose of iberdomide and how well it works in combination with daratumumab, elotuzumab, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Multiple Myeloma
What is being tested?
Bone Marrow Aspiration, Bone Marrow Biopsy and Bone Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
18 Mar 2025to 1 Apr 2031
Phase
Phase 1/2
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

  • Age ≥ 18 years at the time of signing the informed consent form (ICF).
  • Diagnosis of relapsed multiple myeloma with ≤ 3 prior lines of therapy including treatment with proteasome inhibitors (i.e., ixazomib, carfilzomib, bortezomib), immunomodulatory imide drugs (i.e., lenalidomide, pomalidomide), and anti-CD38 drugs (i.e., daratumumab, isatuximab). Patients are required to have received a proteasome inhibitor, immunomodulatory imide drug, or combination of the two drug classes during first-line treatment.
  • Note: Prior treatment with iberdomide is not allowed. Patients should not be refractory simultaneously to all other drugs in the combination.
  • Measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.
  • Hemoglobin ≥ 8.0 g/dL (obtained ≤14 days prior to registration).
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  • Absolute neutrophil count (ANC) ≥ 1000/m^3 (obtained ≤14 days prior to registration).
  • Platelet count ≥ 50,000/mm^3. Note: It is not permissible to transfuse subjects to achieve minimum platelet counts (obtained ≤14 days prior to registration).
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3 x ULN for patients with Gilbert's syndrome) (obtained ≤14 days prior to registration).
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 x ULN and alkaline phosphatase ≤ 1.5 x ULN (obtained ≤14 days prior to registration).
  • Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault (obtained ≤14 days prior to registration).
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. Note: A person of childbearing potential (PCBP) is a person who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) and must:
  • Have 2 negative pregnancy tests prior to starting study treatment and must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
  • AND
  • Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting investigational product, during the study treatment, and for at least 28 days after the last dose of iberdomide, 90 days after the last dose of daratumumab, 7 months after last dose of elotuzumab whichever is longer.
  • NOTE: Non-childbearing potential is defined as follows (by other than medical reasons):
  • ≥ 45 years of age and has not had menses for > 24 months.
  • Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation.
  • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
  • Willingness to follow Pregnancy Prevention Program requirements:
  • Persons of childbearing potential must agree to use a contraceptive method that is highly effective (with a failure rate of < 1% per year), preferably with low user dependency, during the intervention period and for at least 7 months after the last dose of study intervention. These patients must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
  • Persons able to father a child must agree that during the treatment intervention period and for 6 months after the last dose of study treatment (to allow for clearance of any altered sperm), the participant will:
  • Refrain from donating sperm while on study treatment, during dose interruptions and for at least 6 months following last dose of study treatment, PLUS either:
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR,
  • Must agree to use contraception/barrier such as a male condom (even if they have undergone successful vasectomy), and when having sexual intercourse with a person of childbearing potential who is not currently pregnant his partner will use an additional highly effective contraceptive method with a failure rate of < 1% per year.
  • Provide written informed consent.
  • Willingness to provide mandatory bone marrow specimens for correlative research.
  • Willing and able to adhere to the study visit schedule and other protocol requirements. Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willing to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment.

Who cannot join

  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
  • Pregnant persons
  • Nursing persons
  • Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • Receiving any other concurrent chemotherapy, or any ancillary therapy considered investigational.
  • Note: Bisphosphonates are supportive care rather than therapy and are thus allowed while on protocol treatment.
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  • Known to be human immunodeficiency virus (HIV) positive known or suspected active hepatitis C infection or seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]) at registration or ≤ 3 months prior to registration.
  • Note: Participants with resolved hepatitis B infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.
  • EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
  • Evidence of cardiovascular disease risk, as defined by any of the following:
  • Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting ≤ three (3) months prior to registration.
  • Class III or IV heart failure as defined by the New York Heart Association functional classification system [NYHA, 1994]
  • Uncontrolled hypertension
  • History of life-threatening ventricular arrhythmias.
  • Known moderate or severe persistent asthma, or currently has uncontrolled asthma of any classification.
  • Unable or unwilling to undergo protocol required thromboembolism prophylaxis.
  • Has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. John's Wort or related products ≤ 14 days prior to registration.
  • Known allergy to any of the study medications, their analogues or excipients in the various formulations.
  • Major surgery ≤ 14 days prior to registration.
  • Has been treated with an investigational agent (i.e., an agent not commercially available) ≤ 28 days or 5 half-lives (whichever is longer) prior to registration.
  • Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Any co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease.
  • History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide.
  • Peripheral neuropathy grade ≥ 2.
  • Severe acute respiratory syndrome coronavirus 2 infection ≤ 14 days prior to registration for mild or asymptomatic infections OR ≤ 28 days prior to registration for severe/critical illness.
  • Gastrointestinal disease that may significantly alter the absorption of iberdomide.
  • Received a live vaccine ≤ 90 days prior to registration.
  • Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following noninvasive malignancies:
  • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin in situ (stage 0)
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative.
  • Received hydroxychloroquine, quinacrine, chloroquine, methotrexate, leflunomide, sulfasalazine, mycophenolate mofetil, mycophenolic acid ≤ 28 days prior to registration.
  • Received daily nonsteroidal anti-inflammatory drugs (NSAIDs) ≤ 14 days prior to registration. Note: Allowed if dose has been stable for at least 14 days.
  • Received immunomodulating or immunosuppressive therapy as follows:
  • Etanercept ≤ 28 days prior to registration
  • Belimumab ≤ 12 weeks prior to registration
  • B-cell depleting or modulating agents (such as rituximab or anti-CD22 therapy) ≤ 365 days prior to registration.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Moritz Binder, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: Phase 1/2 Trial of Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for Relapsed Multiple Myeloma

This phase I/II trial tests the safety, side effects, and best dose of iberdomide and how well it works in combination with daratumumab, elotuzumab, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Immunotherapy with iberdomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Elotuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving iberdomide in combination with daratumumab, elotuzumab, and dexamethasone may be safe, tolerable and/or effective in patients with relapsed multiple myeloma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the maximum tolerated dose (MTD) of the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone (IberDEd) in patients with relapsed multiple myeloma (MM). (Phase 1 [Dose Confirmation Cohort]) II. To determine the proportion of patients with very good partial response (VGPR) or better with iberdomide, daratumumab, elotuzumab and dexamethasone (IberDEd) when used as therapy in patients with relapsed multiple myeloma. (Phase 2)

SECONDARY OBJECTIVES:

  1. To assess the overall response rate (ORR) and complete response (CR or stringent complete response [sCR]) rate with the combination of iberdomide, daratumumab, elotuzumab and dexamethasone. (Phase 2) II. To assess the progression free survival and overall survival among patients with relapsed multiple myeloma following treatment with the combination of iberdomide, daratumumab, elotuzumab and dexamethasone. (Phase 2) III. To assess the time to response (defined as the time between the date of first dose and the first documented evidence of a partial response or better) following treatment with the combination of iberdomide, daratumumab, elotuzumab and dexamethasone in patients with relapsed MM. (Phase 2) IV. To describe the toxicities associated with the combination of iberdomide, daratumumab, elotuzumab and dexamethasone in patients with relapsed MM. (Phase 2)

CORRELATIVE RESEARCH:

  1. Examine the proportion of next generation flow cytometry assessed minimal residual disease (MRD) negative complete response following therapy with iberdomide in combination with daratumumab, elotuzumab and dexamethasone. (Phase 2)

OUTLINE: This is a dose-escalation study of iberdomide followed by a dose-expansion study.

Patients receive iberdomide orally (PO) once daily (QD) on days 1-21 of each cycle, daratumumab subcutaneously (SC) on days 1, 8, 15, 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive elotuzumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1 and 2, and on day 1 of subsequent cycles and dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12 or at the discretion of the treating physician. Cycles repeat every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy during screening, on study and optionally at disease progression and computed tomography (CT), bone scan, magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT during screening, on study or at the discretion of the treating physician and end of treatment (EOT). Patients may undergo chest x-ray during screening.

After completion of study treatment, patients are followed up at 7 days then 30 days and every 3-6 months for up to 3 years.

Being tested
Bone Marrow Aspiration, Bone Marrow Biopsy, Bone Scan, Chest Radiography, Computed Tomography
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Chest RadiographyProcedure or surgery

    Also called Chest X-ray

    Undergo chest x-ray

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT and/or PET/CT

  • DaratumumabBiological

    Also called Daratumumab Biosimilar HLX15, Daratumumab-fihj, Darzalex, HLX15

    Given SC

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • ElotuzumabBiological

    Also called BMS 901608, BMS-901608, BMS901608, Empliciti

    Given IV

  • IberdomideDrug

    Also called CC 220, CC-220

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT06785415
Study groupRoleWhat they receive
Treatment (iberdomide, daratumumab, elotuzumab, dexamethasone)ExperimentalPatients receive iberdomide PO QD on days 1-21 of each cycle, daratumumab SC on days 1, 8, 15, 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive elotuzumab IV on days 1, 8, 15, and 22 of cycles 1 and 2, and on day 1 of subsequent cycles and dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12 or at the discretion of the treating physician. Cycles repeat every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy during screening, on study and optionally at disease progression and CT, bone scan, MRI or PET/CT during screening, on study or at the discretion of the treating physician and EOT. Patients may undergo chest x-ray during screening.
Receives: Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Bone Scan; Procedure: Chest Radiography; Procedure: Computed Tomography; Biological: Daratumumab; Drug: Dexamethasone; Biological: Elotuzumab; Drug: Iberdomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

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

  1. Maximum tolerated dose (Phase 1)

    The maximum tolerated dose (MTD) of the combination of iberdomide, daratumumab, elotuzumab, and dexamethasone (IberDEd) will be defined as the highest tested dose level that is determined to have acceptable toxicity and tolerability based on dose limiting toxicity definitions.

    Measured: Up to 28 days

  2. Proportion of patients with very good partial response (VGPR) or better (Phase 2)

    Will be defined as a patient who has achieved a VGPR, complete response (CR), or stringent complete response (sCR) and maintained it on two consecutive evaluations at any time during therapy per International Myeloma Working Group (IMWG) criteria.

    Measured: Up to 3 years

Secondary outcomes (6)

  1. Overall response rate (Phase 2)

    Will be assessed as stringent Complete Response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), Minimal Response (MR), stable disease (SD), or progressive disease (PD).

    Measured: Up to 3 years

  2. Complete response rate (Phase 2)

    Will be estimated by the total number of patients who achieve sCR or CR.

    Measured: Up to 3 years

  3. Progression-free survival (Phase 2)

    Defined as the time from registration to the earliest date of documentation of disease progression, relapse, or death due to any cause.

    Measured: Up to 3 years

  4. Overall survival (Phase 2)

    Overall survival (OS) is defined as the time from registration to death due to any cause.

    Measured: Up to 3 years

  5. Time to response (Phase 2)

    Defined in patients who have achieved a response (PR or better) as the time from registration to the first incidence of a response.

    Measured: Up to 3 years

  6. Incidence of adverse events (AEs) (Phase 2)

    Will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum grade for each type of AE will be recorded for each patient.

    Measured: Up to 3 years

Timeline

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

  1. First posted21 Jan 2025
  2. Study start18 Mar 2025
  3. Primary completion1 Apr 2031 (estimated)
  4. Study completion1 Apr 2031 (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
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06785415
Sponsor's protocol ID
MC230812
Other IDs
NCI-2025-00138, 24-010000, MC230812
Status last verified
Jun 2026
First submitted
16 Jan 2025
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bone Marrow Aspiration, Bone Marrow Biopsy and Bone Scan in people with Recurrent Multiple Myeloma, run by Mayo Clinic 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 29 inclusion and 40 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 25 Jun 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (Phase 1) (time frame: Up to 28 days). 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?

On the ClinicalTrials.gov record for NCT06785415.

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 25 Jun 2026.

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