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Monoclonal Antibodies
Forimtamig for Multiple Myeloma
Phase 1
Waitlist Available
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called Forimtamig on patients with a type of cancer called multiple myeloma. These patients have no other treatment options or cannot tolerate existing treatments. The drug aims to either kill the cancer cells or help the immune system fight them.
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.
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.
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 belowSelect...
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:Select...
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.
Select...
I have had side effects from previous immune therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,096,819 Total Patients Enrolled
13 Trials studying Multiple Myeloma
2,005 Patients Enrolled for Multiple Myeloma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
895,765 Total Patients Enrolled
19 Trials studying Multiple Myeloma
2,686 Patients Enrolled for Multiple Myeloma
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.