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Multiple MyelomaPhase 2NCT07454382

A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma

A Phase 2 study testing Elranatamab-bcmm and Cyclophosphamide in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites 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
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Trial summary

The purpose of this study is to find out whether the combination of elranatamab and cyclophosphamide is an effective treatment for people with relapsed/refractory multiple myeloma (MM) who have risk factors that may affect how well their disease would respond to elranatamab alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Elranatamab-bcmm and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
7 sitesUnited States
Study dates
27 Feb 2026to 27 Aug 2029
Phase
Phase 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

  • Documentation of Disease:
  • Patients must have pathologically confirmed diagnosis of multiple myeloma (MM) as defined according to 2014 IMWG criteria.
  • Measurable disease defined by at least 1 of the following:
  • Serum M-protein ≥0.5 g/dL by SPEP
  • Serum immunoglobulin free light chain ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (<0.26 or >1.65)
  • Urinary M-protein excretion ≥200 mg/24 hours by UPEP
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  • Bone marrow plasma cell percentage (in aspirate or biopsy, whichever is higher) of ≥30%
  • Myeloma bone lesion or plasmacytoma lesion with a single diameter of ≥2 cm
  • Adverse risk features defined as having ≥1 of the following:
  • Presence of extramedullary myeloma identifiable by 18F-FDG PET/CT
  • Serum beta-2-microglobulin (B2M) level ≥5.5 mg/dL
  • Bone marrow plasma cell percentage (in aspirate or biopsy, whichever is higher) of ≥50%
  • Prior Treatment Exposure:
  • Participants have received at least 1 prior lines of therapy for MM including:
  • At least 1 IMiD (thalidomide, lenalidomide or pomalidomide)
  • At least 1 PI (bortezomib, carfilzomib or ixazomib)
  • At least 1 anti-CD38 monoclonal antibody (daratumumab or isatuximab)
  • Age ≥ 18
  • ECOG Performance Status ≤ 2 (See Appendix I for performance status criteria)
  • Not Pregnant and Not Nursing
  • The effects of elranatamab and cyclophosphamide on the developing human fetus are unknown. For this reason and because cyclophosphamide as well as other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months following the completion of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.
  • Required Organ Function:
  • Adequate hematologic function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3(use of G-CSF is permitted if completed at ≥7 days prior to planned start of study treatment)
  • Platelets ≥ 25,000 cells/mm3 (transfusion support is permitted)
  • Hemoglobin ≥ 8 g/dl (transfusion support is permitted)
  • Adequate renal function defined as follows:
  • Creatinine clearance (CrCL) of ≥15 mL/min by the CKD-EPI formula, Cockcroft-Gault formula, or with direct measurement.
  • Adequate hepatic function defined as follows:
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
  • AST and ALT ≤3 x institutional ULN
  • Adequate cardiac function defined as follows:
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function (see exclusionary cardiac conditions below)

Who cannot join

  • Exclusionary Prior Treatments, Diagnoses and Comorbid Conditions
  • Previous treatment with a CD3 redirecting bispecific or trispecific antibody for multiple myeloma.
  • Plasma cell leukemia (as defined by the IMWG49), smoldering multiple myeloma, Waldenström's macroglobulinemia, amyloidosis, or POEMS syndrome.
  • Active central nervous system involvement or clinical signs of myelomatous meningeal involvement.
  • History of autologous stem cell transplant within 8 weeks prior to enrollment.
  • Active graft-versus-host disease or history of allogeneic stem cell transplant within 12 weeks prior to enrollment.
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  • Clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
  • Acute myocardial infarction, acute coronary syndromes (e.g., unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, pericardial effusion)
  • Clinically significant cardiac arrhythmias (e.g., uncontrolled atrial fibrillation, uncontrolled paroxysmal supraventricular tachycardia, or ventricular tachycardia)
  • Decompensated heart failure syndrome. To be eligible for this trial, patients should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).
  • Thromboembolic or cerebrovascular events (e.g., transient ischemic attack, cerebrovascular accident, or pulmonary embolism with evidence of right heart strain)
  • Prolonged QT syndrome (or QTcF >470 msec at screening).
  • Active or uncontrolled bacterial, HIV, HBV, HCV, SARS-CoV-2, other viral, or fungal infections. Acute bacterial, viral, or fungal infections must be resolved prior to enrollment. Specific considerations for certain infections listed below:
  • HIV
  • HIV seropositive participants who are otherwise healthy and at low risk for AIDS-related outcomes could be considered eligible. Potential eligibility for a specific HIV-positive protocol candidate should be evaluated and discussed with the investigator prior to any screening, based on current and past CD4 and T-cell counts, history (if any) of AIDS defining conditions (e.g., opportunistic infections), and status of HIV treatment.
  • HBV
  • Participants with positive HBsAg or detectable HBV DNA may be permitted provided they have been taking appropriate anti-viral medication (e.g. entecavir, tenofovir) for at least 28 days prior to enrollment, willing to continue therapy, and with screening HBV DNA is <2 × 10³ IU/mL, without evidence of hepatic decompensation. Participants with negative HBsAg but positive anti-HBc antibody, indicating immunity from prior natural infection, are eligible provided their screening HBV DNA is <2 × 10³ IU/mL, they are willing to take an appropriate anti-viral medication and undergo HBV DNA monitoring during the study.
  • HCV
  • Positive HCV antibody is indicative of prior infection but may not necessarily render a potential participant ineligible. If exposure to HCV is recent, the HCV antibody test may not yet be positive. In this case, testing for HCV RNA is recommended. Patients with a positive HCV antibody must undergo HCV RNA PCR, and those with detectable HCV RNA will be excluded.
  • COVID-19/SARS-CoV-2
  • COVID-19/SARS-CoV-2: COVID-19/SARS-CoV-2 PCR testing of nasopharyngynx is mandated at the screening visit. Participants with a positive PCR test result within 7 days prior to enrollment or those suspected of having an active COVID-19/SARS-CoV-2 infection will be excluded from study enrollment.
  • Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, Stage 0/1 malignancy with minimal risk of recurrence, or low risk neoplasm that does not require active therapy and has demonstrated stability over a 2-year surveillance period.
  • History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
  • History of organ transplant requiring immunosuppressive therapy.
  • Gastrointestinal conditions that would alter the absorption of cyclophosphamide.
  • Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • History of anaphylaxis or severe hypersensitivity to cyclophosphamide.
  • Receipt of a live attenuated vaccine within 4 weeks of the first dose of study intervention.
  • Receipt of a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14-day period before the first dose of study intervention.
  • Participant unable or unwilling to undergo protocol required anti-infection prophylaxis.
  • Previous administration with an investigational product (drug or vaccine) within 28 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is shorter). A participant may be eligible even if they are in the follow-up phase of an investigational study if they meet the criterion for time elapsed from previous administration of investigational product. Cases must be discussed with the investigator to judge eligibility.

Trial locations and contacts

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

Alexander Lesokhin, MD contact

646-608-3717

lesokhia@mskcc.org

Carlyn Rose Tan, MD contact

646-608-3778

TanC4@mskcc.org

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Alexander Lesokhin, MD, 646-608-3717

    Recruiting

  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All Protocol Activities)

    Commack, New York, 11725

    Alexander Lesokhin, MD, 646-608-3717

    Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

    Alexander Lesokhin, MD, 646-608-3717

    Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748

    Alexander Lesokhin, MD, 646-608-3717

    Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645

    Alexander Lesokhin, MD, 646-608-3717

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Alexander Lesokhin, MD, 646-608-3717

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Alexander Lesokhin, MD, 646-608-3717

    Recruiting

Other trials in United States

About this study

Official title: Phase 2 Trial of Elranatamab With Cyclophosphamide in Relapsed/Refractory Multiple Myeloma

The purpose of this study is to find out whether the combination of elranatamab and cyclophosphamide is an effective treatment for people with relapsed/refractory multiple myeloma (MM) who have risk factors that may affect how well their disease would respond to elranatamab alone.

Being tested
Elranatamab-bcmm, Cyclophosphamide
Keywords
Multiple Myeloma, Memorial Sloan Kettering Cancer Center, 26-006
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Elranatamab-bcmmBiological

    Elranatamab-bcmm is a recombinant, humanized, bispecific IgG2 kappa antibody

  • CyclophosphamideDrug

    Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards

Study groups in NCT07454382
Study groupRoleWhat they receive
Participants with Multiple MyelomaExperimentalParticipants must have pathologically confirmed diagnosis of multiple myeloma (MM) as defined according to 2014 IMWG criteria
Receives: Biological: Elranatamab-bcmm; Drug: Cyclophosphamide

What is being measured

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

  1. Complete response rate

    To evaluate the complete response rate of elranatamab with cyclophosphamide in participants with relapsed or refractory multiple myeloma with adverse risk factors.

    Measured: 6 months

Timeline

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

  1. First posted6 Mar 2026
  2. Study start27 Feb 2026
  3. Primary completion27 Aug 2029 (estimated)
  4. Study completion27 Aug 2029 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07454382
Sponsor's protocol ID
26-006
Status last verified
Jun 2026
First submitted
2 Mar 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elranatamab-bcmm and Cyclophosphamide in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 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 33 inclusion and 31 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 16 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 7 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 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 Alexander Lesokhin, MD (646-608-3717, lesokhia@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: 6 months). 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 NCT07454382.

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 16 Jun 2026.

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