Elranatamab in R/R Multiple Myeloma

NCT06138275 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-402
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.

Conditions

Refractory Multiple Myeloma; Relapse Multiple Myeloma; Multiple Myeloma

Keywords

relapsed/refractory multiple myeloma

Outcome Measures

Primary Outcomes (2)

• Complete Response (CR) rate or stringent CR (sCR) post consolidation therapy

  Disease response will be assessed using the International Myeloma Working Group Response Criteria (IMWG)

  The time from start of treatment to first date that progressive disease is objectively documented or death due to any cause, for up to 5 years. Participants without events reported are censored at the last disease evaluation.

• Progression-free survival

  Progression-Free Survival (PFS) is defined as the time from or registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. This will be estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.

  The time from registration to the earlier of progression or death due to any cause, for up to 5 years. Participants alive without disease progression are censored at date of last disease evaluation

Secondary Outcomes (7)

• Incidence of adverse events (AEs)

  3 years

• Objective response rate (ORR)

  From start of treatment to 2 years post-treatment

• Overall survival (OS)

  From start of treatment to 2 years post-treatment

• Minimum Residual Disease (MRD)-positive to MRD-negative conversion rate

  6 months

• Rate of sustained MRD-negativity of ≥6 or ≥12 months

  6 years

Study Arms (1)

Elranatamab

EXPERIMENTAL

Elranatamab subcutaneous injections at pre-determined doses, administered at the following timepoints during each 28-day cycle: Cycle 1: Days 1, 4, 8, 15, and 22; Cycle 2: Days 1, 8, 15, and 22 ; Cycles 3-6: Days 1 and 15

Drug: Elranatamab

Interventions

Elranatamab DRUG

subcutaneous (under the skin) injection

Elranatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has given voluntary signed written informed consent before performance of any study related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Male or female participants age ≥ 18 years
• The effects of elranatamab on the developing human fetus are unknown. For this reason and because anti-BCMA bispecific antibodies are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of elranatamab administration.
• Prior diagnosis of MM as defined according to IMWG criteria.
• Measurable disease of multiple myeloma as defined by at least one of the following prior to idecabtagene vicleucel infusion:
• Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval
• ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
• Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio (\<0.26 or \>1.65)
• Previously treated relapsed and refractory multiple myeloma following idecabtagene vicleucel as infusion as standard of care who have achieved at least a PR or better per IMWG criteria. Patients will have received idecabtagene per label including after at least 4 prior lines of therapy and relapsed after an immunomodulatory drug (IMiD), a proteasome inhibitor and an Anti-CD38 monoclonal antibody
• left ventricular ejection fraction (LVEF) ≥40% as determined by a multiple gated acquisition scan (MUGA) scan or echocardiogram (ECHO).
• Participants must meet the following organ and marrow function as defined below:
• Absolute neutrophil count ≥1000/microlitre (mcL). Use of granulocyte-colony stimulating factors is permitted if completed at least 7 days prior to planned start of dosing.
• Platelet count ≥25,000/mcL. Platelet transfusion support is permitted if completed at least 7 days prior to planned start of dosing.
• Hemoglobin ≥8 g/dL. Red blood cell transfusion support is permitted if completed at least 7 days prior to planned start of dosing.

You may not qualify if:

• Patients with smoldering MM, plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.
• Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease (GVHD).
• Active hepatitis B virus, hepatitis C virus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.
• Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
• Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
• Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
• Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \[unless associated with a central venous access complication\] or pulmonary embolism);
• Prolonged QT syndrome (or triplicate average QTcF \>470 msec at screening).
• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
• Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
• History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
• Previous treatment with an anti-BCMA (B-cell maturation antigen) bispecific antibody.
• Pregnant women are excluded from this study because elranatamab is an anti-BCMA bispecific antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with elranatamab, breastfeeding should be discontinued if the mother is treated with elranatamab.
• Known or suspected hypersensitivity to the study intervention or any of its excipients.
• Participants who are receiving any other investigational agents for this condition (if appropriate only).

Sponsors & Collaborators

• Pfizer: collaborator
• Massachusetts General Hospital: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Noopur Raje, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noopur Raje, MD

CONTACT

617-726-0711; nraje@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 18, 2023
• Study Start: March 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (3)