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Monoclonal Antibodies

Elranatamab Combinations for Multiple Myeloma

Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
ECOG performance status 0 -1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with cancer.

Who is the study for?
This trial is for adults with multiple myeloma who've tried at least three other treatments without success, including IMiDs, proteasome inhibitors, and anti-CD38 antibodies. They must have measurable disease indicators and be in good physical condition. People can't join if they've had certain blood disorders or heart issues recently, a stem cell transplant within the last 12 weeks, or any investigational drug use in the past month.Check my eligibility
What is being tested?
The study tests Elranatamab combined with either lenalidomide plus dexamethasone or Nirogacestat to find out the best dose and see how well it works against multiple myeloma. Participants will receive these combinations to assess their effectiveness as cancer treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fatigue, fever, bone pain; digestive disturbances like nausea; potential impact on blood cells leading to anemia or increased risk of infection; and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition did not improve after treatments with IMiD, proteasome inhibitor, and anti-CD38 antibody.
Select...
I am fully active or can carry out light work.
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My multiple myeloma has returned or didn't respond after 3 treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed approximately every 1 to 3 cycles (each cycle approximately 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed approximately every 1 to 3 cycles (each cycle approximately 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sub-Study A Phase 1: Dose Limiting Toxicity
Sub-Study A Phase 2: Objective Response Rate
Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity
Secondary outcome measures
Sub-Study A Phase 1 and 2: Duration of Response
Sub-Study A Phase 1 and Phase 2: Complete Response Rate
Sub-Study A Phase 1 and Phase 2: Concentrations of elranatamab and/or nirogacestat
+27 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sub-Study BExperimental Treatment1 Intervention
BCMA-CD3 bispecific antibody + immunomodulatory drug
Group II: Sub-Study AExperimental Treatment1 Intervention
BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,906 Total Patients Enrolled
35 Trials studying Multiple Myeloma
9,770 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,101 Total Patients Enrolled
25 Trials studying Multiple Myeloma
5,080 Patients Enrolled for Multiple Myeloma

Media Library

Elranatamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05090566 — Phase 2
Multiple Myeloma Research Study Groups: Sub-Study B, Sub-Study A
Multiple Myeloma Clinical Trial 2023: Elranatamab Highlights & Side Effects. Trial Name: NCT05090566 — Phase 2
Elranatamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05090566 — Phase 2

Frequently Asked Questions

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

What is the major aim of this investigation?

"According to the trial sponsor, Pfizer, Sub-Study A Phase 2: Objective Response Rate will be considered as the primary outcome during an examination period of 42 days. Secondary outcomes that this study will assess include Sub-Study A Phase 1: Time to Maximum Concentration (Tmax) for elranatamab administration, Sub-Study B Phase 1 Escalation and Expansion: Duration of Complete Response (IMWG response criteria), and Progression Free Survival (IMWG response criteria)."

Answered by AI

Are there currently any vacancies for participants in this clinical experiment?

"As per clinicaltrials.gov, this trial is actively recruiting participants and updating their progress since being posted on October 27th 2021. The information was last modified on November 21st 2022."

Answered by AI

How many participants are slated to take part in this experiment?

"Pfizer, the sponsor organisation in charge of this trial, requires 105 suitable patients to operate properly. The pharmaceutical giant will be using two medical centres for its work: namely, The University of Kansas Hospital located in Boston and Massachusetts General Hospital situated in Westwood."

Answered by AI

Are there any other research initiatives investigating the efficacy of Elranatamab + lenalidomide + dexamethasone's therapeutic potential?

"Elranatamab + lenalidomide + dexamethasone was first researched in 2013 at National Institutes of Health Clinical Center. There have been 1 concluded studies, with 12 active trials taking place across the United States - many of them situated in Boston, Massachusetts."

Answered by AI

How many research facilities are administering this trial?

"This trial has 25 recruitment sites, such as The University of Kansas Hospital in Boston and Mass General Hospital in Westwood. Additionally, there are 22 other enrollment centres including the University of Kansas Cancer Center located in Fairway."

Answered by AI

What risks must patients consider when taking Elranatamab, lenalidomide and dexamethasone?

"As Elranatamab + lenalidomide + dexamethasone is currently in Phase 2 trials, there has been some evidence for safety but not efficacy. Thus our team at Power evaluated this medication with a score of 2 on the 1-3 scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
2021. "MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05090566.
~40 spots leftby Aug 2025
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