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Elranatamab for Multiple Myeloma

Phase 2

Recruiting

Led By Noopur Raje, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior diagnosis of MM as defined according to IMWG criteria

Previously treated relapsed and refractory multiple myeloma following idecabtagene vicleucel infusion as standard of care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

Study Summary

This trial will test if a new drug can help people with a certain form of blood cancer live longer.

Who is the study for?

Adults with relapsed and refractory multiple myeloma who have previously been treated with idecabtagene vicleucel. Participants must be over 18, agree to use contraception, have measurable disease per specific criteria, good organ/marrow function, an ECOG status ≤1, and a heart ejection fraction ≥40%. Exclusions include recent live vaccines or investigational drugs, certain MM-related conditions or cardiovascular issues within the last 6 months.Check my eligibility

What is being tested?

The trial is testing elranatamab's effectiveness in reducing the risk of disease progression in patients with multiple myeloma after treatment with idecabtagene vicleucel. It aims to see if this drug can help when the cancer comes back or doesn't respond to previous treatments.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical reactions associated with immunotherapy such as fatigue, infusion reactions (like fever or chills), allergic responses to components of elranatamab, and possible impacts on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple myeloma according to standard criteria.

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I have multiple myeloma that came back or didn't respond after receiving idecabtagene vicleucel.

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My organ and bone marrow functions are within required levels.

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My liver is functioning well.

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My multiple myeloma can be measured by tests.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Progression-free survival

Secondary outcome measures

Duration of response (DOR)

Incidence of adverse events (AEs)

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

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ElranatamabExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elranatamab

2022

N/A

~510

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,609 Total Patients Enrolled

35 Trials studying Multiple Myeloma

2,606 Patients Enrolled for Multiple Myeloma

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,950 Total Patients Enrolled

35 Trials studying Multiple Myeloma

9,858 Patients Enrolled for Multiple Myeloma

Noopur Raje, MDPrincipal InvestigatorMassachusetts General Hospital

6 Previous Clinical Trials

236 Total Patients Enrolled

6 Trials studying Multiple Myeloma

236 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this trial?

"Unfortunately, according to clinicaltrials.gov records, this medical trial has ceased recruitment efforts - data was last modified on November 15th 2023. Despite the lack of available opportunities with this research study, 830 other trials are actively seeking candidates right now."

Answered by AI

Has the FDA approved Elranatamab for therapeutic use?

"The safety of Elranatamab was assessed and given a score of 2 due to it being in its second phase, meaning that only preliminary data exists concerning the drug's efficacy."

Answered by AI

What is the primary goal of this exploration?

"The primary objective of this trial is to evaluate Progression-Free Survival, or the period between commencement of treatment and either documented progression or death due to any cause. Secondary outcomes include Objective Response Rate (ORR), Overall Survival (OS) calculated through Kaplan Meier methods with medians and 95% CI's, as well as Minimum Residual Disease (MRD)-positive to MRD-negative conversion rate measured by Clopper-Pearson method."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Elranatamab in R/R Multiple Myeloma

Noopur Raje 2024. "Elranatamab in R/R Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06138275.