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Monoclonal Antibodies

Part 2 Dose Randomization for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed from baseline up to 90 days after last dose of study treatment

Awards & highlights

Study Summary

This trial aims to see how safe and tolerable it is to use elranatamab with iberdomide for patients with relapsed or refractory multiple myeloma. The study will

Who is the study for?

This trial is for adults with multiple myeloma that has come back or hasn't improved after treatment. They should have had 1-4 prior treatments including specific drugs, be in good physical condition (ECOG 0-1), and meet certain lab criteria like protein levels in the blood or urine.Check my eligibility

What is being tested?

The study tests how safe and effective the combination of Elranatamab (injection) and Iberdomide (oral pill) is for treating multiple myeloma. It's divided into two parts: first to find a safe dose and second to confirm this dose can help patients whose cancer returned or resisted previous treatments.See study design

What are the potential side effects?

While not specified here, side effects may include reactions at the injection site, changes in blood counts, fatigue, digestive issues from oral pills, potential drug interactions, and other typical chemotherapy-related side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed from baseline up to 90 days after last dose of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed from baseline up to 90 days after last dose of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from baseline up to 90 days after last dose of study treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1: Number of participants with dose limiting toxicity (DLT)

Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment

Secondary outcome measures

Part 1 and Part 2: Concentrations of elranatamab

Part 1 and Part 2: Concentrations of iberdomide

Part 1 and Part 2: Duration of Complete Response (DOCR)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 Dose RandomizationExperimental Treatment2 Interventions

Randomized elranatamab plus iberdomide

Group II: Part 1 Dose EscalationExperimental Treatment2 Interventions

Non-randomized elranatamab plus iberdomide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elranatamab

2022

N/A

~510

Iberdomide

2021

Completed Phase 1

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,129,964 Total Patients Enrolled

87 Trials studying Multiple Myeloma

29,820 Patients Enrolled for Multiple Myeloma

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,882 Total Patients Enrolled

35 Trials studying Multiple Myeloma

9,790 Patients Enrolled for Multiple Myeloma

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,100 Total Patients Enrolled

25 Trials studying Multiple Myeloma

5,100 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.

What is the current number of individuals who have been admitted into this clinical research study?

"Yes, according to the details on clinicaltrials.gov, this investigation is actively enlisting participants. The trial was initially published on February 20th, 2024 and last revised on March 1st, 2024. It aims to recruit a total of 100 patients from one designated location."

Answered by AI

Has the FDA granted approval for Part 1 Dose Escalation?

"The safety assessment for Part 1 Dose Escalation is rated as 1 by our team at Power, indicating the preliminary nature of this Phase 1 trial with limited evidence supporting both safety and efficacy."

Answered by AI

Are patients currently eligible to participate in this ongoing research study?

"According to the details available on clinicaltrials.gov, this trial is actively seeking participants. It was first listed on 2/20/2024 and most recently revised on 3/1/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

2024. "A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06215118.