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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
Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 up to cycle 1 day 35
Awards & highlights

Study 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 relapsed/refractory multiple myeloma and cannot tolerate or have no other standard treatments left.
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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.

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.

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Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,574 Total Patients Enrolled
13 Trials studying Multiple Myeloma
2,005 Patients Enrolled for Multiple Myeloma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,022 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any adverse reactions associated with RO7425781 for patients?

"The safety and efficacy of RO7425781 is limited, earning it a score of 1 on our team's scale from 1 to 3. As this medical trial is in its first phase, there are few data points available to assess the drug beyond preliminary studies."

Answered by AI

Are there open vacancies for volunteers to join this research project?

"Affirmative, the clinicaltrials.gov website displays that this research trial is actively searching for participants. It was first published on November 11th 2020 and its most recent update occurred on October 18th 2022. This survey needs 400 patients from 2 different sites to be enrolled."

Answered by AI

To what extent are individuals being administered treatments in this experiment?

"Affirmative. According to information published on clinicaltrials.gov, this research effort is actively recruiting for 400 participants across two sites and was originally posted in November 11th 2020 with the last update being October 18th 2022."

Answered by AI
~188 spots leftby Aug 2026