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CAR T-cell Therapy

Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab for Multiple Myeloma

Phase 1 & 2

Recruiting

Research Sponsored by Hoffmann-La Roche

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 up to approximately 24 months

Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of forimtamig in treating people with relapsed or refractory multiple myeloma. Participants will receive forimtamig alone or in combination with

Who is the study for?

This trial is for people with relapsed or refractory multiple myeloma who have a good performance status, expect to live at least 12 more weeks, and have recovered from previous cancer treatments. They must have measurable disease progression after their last treatment.Check my eligibility

What is being tested?

The study tests the safety and initial effectiveness of Forimtamig alone or combined with Carfilzomib or Daratumumab in treating multiple myeloma. It has two parts: finding the right dose and then seeing how well it works at that dose.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation, infusion-related symptoms, fatigue, nausea, blood count changes, kidney or liver function alterations among others specific to each drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months 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)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria

Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria

Percentage of Participants with Adverse Events (AEs)

+1 more

Secondary outcome measures

Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria

Overall Survival (OS) as Determined by the Investigator per IMWG Criteria

Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig

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Trial Design

9Treatment groups

Experimental Treatment

Group I: Dose Exploration Phase: Forimtamig (Dose 3) + DaratumumabExperimental Treatment2 Interventions

Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Group II: Dose Exploration Phase: Forimtamig (Dose 3) + CarfilzomibExperimental Treatment2 Interventions

Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.

Group III: Dose Exploration Phase: Forimtamig (Dose 2) + DaratumumabExperimental Treatment2 Interventions

Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Group IV: Dose Exploration Phase: Forimtamig (Dose 2) + CarfilzomibExperimental Treatment2 Interventions

Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.

Group V: Dose Exploration Phase: Forimtamig (Dose 1) + DaratumumabExperimental Treatment2 Interventions

Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.

Group VI: Dose Exploration Phase: Forimtamig (Dose 1) + CarfilzomibExperimental Treatment2 Interventions

Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression.

Group VII: Dose Expansion Phase: Forimtamig + DaratumumabExperimental Treatment2 Interventions

Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.

Group VIII: Dose Expansion Phase: Forimtamig + CarfilzomibExperimental Treatment2 Interventions

Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression.

Group IX: Dose Expansion Phase: ForimtamigExperimental Treatment1 Intervention

Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase until disease progression or completion of 12 months of treatment, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carfilzomib

2017

Completed Phase 3

~1440

Daratumumab

2014

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,907 Total Patients Enrolled

13 Trials studying Multiple Myeloma

2,169 Patients Enrolled for Multiple Myeloma

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,624 Total Patients Enrolled

19 Trials studying Multiple Myeloma

2,892 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.

Are there any available openings for patients to participate in this study?

"As stated on clinicaltrials.gov, this investigation is actively enrolling volunteers. The trial was initially published on December 12th, 2023, and recently revised on March 15th, 2024."

Answered by AI

Has the Dose Expansion Phase involving Forimtamig and Carfilzomib been granted approval by the FDA?

"According to Power's evaluation, the safety rating for the Dose Expansion Phase involving Forimtamig + Carfilzomib is a 1. This assessment stems from it being a Phase 1 trial with minimal supporting data on both safety and effectiveness."

Answered by AI

What is the current capacity for patient enrollment in this clinical trial?

"To proceed with the research, a total of 316 eligible participants are required to meet the study's criteria. Hoffmann-La Roche will oversee operations from various locations such as Aarhus Universitetshospital Skejby; Blodsygdomme - Klinisk Forsknings Enhed in Aarhus N, Navarra and CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique in Nantes, South Australia."

Answered by AI

Do numerous medical centers in the United States participate in this particular research study?

"The current phase of this research initiative is operational at 16 distinct sites. Noteworthy locations include Aarhus N, Nantes, and København Ø among others. Opting for the nearest clinic will help reduce travel commitments for potential participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

2023. "A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055075.