What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib, lenalidomide, and dexamethasone, are associated with a range of side effects. Bortezomib can cause peripheral neuropathy, gastrointestinal issues (nausea, diarrhea, constipation), and fatigue. Lenalidomide often leads to hematologic toxicities like neutropenia and thrombocytopenia, as well as gastrointestinal symptoms and fatigue. Dexamethasone, a corticosteroid, can result in hyperglycemia, increased risk of infections, and mood changes. Other treatments like carfilzomib and pomalidomide share similar side effects, including cardiovascular issues and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, particularly for relapsed or refractory cases. Notable drugs include bortezomib, a proteasome inhibitor; lenalidomide, an immunomodulatory drug; and dexamethasone, a corticosteroid. Combination regimens such as bortezomib with melphalan and prednisone, and lenalidomide with dexamethasone, have shown efficacy in clinical trials. Additionally, monoclonal antibodies like daratumumab and elotuzumab have been approved for use in combination with other agents. These treatments aim to target different pathways involved in Multiple Myeloma, providing a multi-faceted approach to disease management.

What other types of research exist?

Promising novel alternatives to Forimtamig for Multiple Myeloma patients include: 1) Bispecific T-cell engagers (BiTEs) such as teclistamab, which targets BCMA and CD3. 2) CAR T-cell therapies like idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti), which target BCMA. 3) Antibody-drug conjugates (ADCs) such as belantamab mafodotin, which also targets BCMA. These therapies have shown significant efficacy in clinical trials and are emerging as important options for relapsed or refractory MM.

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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 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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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.

0 / 7Eligibility criteria met

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.