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Monoclonal Antibodies

Forimtamig for Multiple Myeloma

Phase 1
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
Agreement to provide protocol-specific biopsy material
Previously diagnosed with Multiple Myeloma (MM) based on standard criteria
Must not have
Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication
Prior solid organ transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 up to cycle 1 day 35
Awards & highlights

Summary

This trialwill test a new drug for multiple myeloma in humans with no standard treatment or who cannot tolerate existing therapies.

Who is the study for?
This trial is for adults with relapsed or refractory Multiple Myeloma who've tried other treatments like IMiDs and PIs but can't use them anymore. They should have a life expectancy of at least 12 weeks, measurable disease, and be willing to follow birth control guidelines. People can't join if they're pregnant, breastfeeding, recently used certain cancer drugs or immunotherapies, had organ transplants, active autoimmune diseases, or stem cell transplantation within the last 100 days.Check my eligibility
What is being tested?
The study tests escalating doses of Forimtamig in two parts: first finding the right dose (Part 1) and then giving that dose to more people to see how well it works (Part 2). It's for patients with no standard treatment options left or those intolerant to existing therapies.See study design
What are the potential side effects?
Since this is a first-in-human study for Forimtamig, specific side effects are not yet fully known. However, participants may experience typical drug-related reactions such as infusion reactions, fatigue, digestive issues and potential impacts on blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to provide tissue samples for the study.
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I have been diagnosed with Multiple Myeloma.
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I agree to not have sex or use birth control and not donate sperm.
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My side effects from previous cancer treatments are mild or gone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a stem cell transplant within the last 100 days or have ongoing signs of graft versus host disease.
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I have had a solid organ transplant.
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I have had side effects from previous immune therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 up to cycle 1 day 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 up to cycle 1 day 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Apparent Clearance (CL/F) of Forimtamig
Area Under the Curve (AUC) at Various Time Intervals of Forimtamig
Duration of Response (DOR)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part II: Dose ExpansionExperimental Treatment1 Intervention
Dose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase.
Group II: Part I: Dose EscalationExperimental Treatment1 Intervention
Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Multiple Myeloma include lenalidomide, dexamethasone, bortezomib, and monoclonal antibodies like daratumumab. Lenalidomide works by modulating the immune system and inhibiting angiogenesis, which helps to reduce the growth of myeloma cells. Dexamethasone is a corticosteroid that reduces inflammation and suppresses the immune response, aiding in the reduction of myeloma cell proliferation. Bortezomib is a proteasome inhibitor that disrupts protein degradation in cancer cells, leading to cell death. Monoclonal antibodies like daratumumab target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. These mechanisms are crucial for Multiple Myeloma patients as they target the disease through different pathways, improving treatment efficacy and patient outcomes.

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Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,091,155 Total Patients Enrolled
13 Trials studying Multiple Myeloma
2,005 Patients Enrolled for Multiple Myeloma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
889,826 Total Patients Enrolled
19 Trials studying Multiple Myeloma
2,728 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Clinical Trial 2023: RO7425781 Highlights & Side Effects. Trial Name: NCT04557150 — Phase 1
~167 spots leftby Aug 2026
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