NCT07454382

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
40mo left

Started Feb 2026

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Feb 2026Aug 2029

Study Start

First participant enrolled

February 27, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2029

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

March 2, 2026

Last Update Submit

March 2, 2026

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaMemorial Sloan Kettering Cancer Center26-006

Outcome Measures

Primary Outcomes (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.

    6 months

Study Arms (1)

Participants with Multiple Myeloma

EXPERIMENTAL

Participants must have pathologically confirmed diagnosis of multiple myeloma (MM) as defined according to 2014 IMWG criteria

Biological: Elranatamab-bcmmDrug: Cyclophosphamide

Interventions

Elranatamab-bcmmBIOLOGICAL

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

Participants with Multiple Myeloma
CyclophosphamideDRUG

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

Participants with Multiple Myeloma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)
  • +17 more criteria

You may not qualify if:

  • 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.
  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Alexander Lesokhin, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Lesokhin, MD

CONTACT

646-608-3717lesokhia@mskcc.org

Carlyn Rose Tan, MD

CONTACT

646-608-3778TanC4@mskcc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

February 27, 2026

Primary Completion (Estimated)

August 27, 2029

Study Completion (Estimated)

August 27, 2029

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)