A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
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- Full Title:
- An Open-Label, Randomized Phase IB/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
- Myeloma stage or condition:
- Relapsed or Refractory Multiple Myeloma
- Study phase:
- Phase 1/Phase 2
- Summary/Purpose:
- The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.
- Detailed Description:
- Not available
- Treatments:
- Drug : Forimtamig
Forimtamig will be administered SC at different doses during dose exploration phase. Forimtamig will be administered at a fixed dose determined during dose exploration phase in dose expansion phase.
- Drug : Carfilzomib
Carfilzomib will be administered via IV infusion in combination with forimtamig.
- Drug : Daratumumab
Daratumumab will be administered via SC injection in combination with forimtamig.
- Study Arms:
- Experimental : Dose Exploration Phase: Forimtamig (Dose 1) + Carfilzomib
Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression. - Experimental : Dose Exploration Phase: Forimtamig (Dose 2) + Carfilzomib
Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression. - Experimental : Dose Exploration Phase: Forimtamig (Dose 3) + Carfilzomib
Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression. - Experimental : Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab
Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. - Experimental : Dose Exploration Phase: Forimtamig (Dose 2) + Daratumumab
Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. - Experimental : Dose Exploration Phase: Forimtamig (Dose 3) + Daratumumab
Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression. - Experimental : Dose Expansion Phase: Forimtamig
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. - Experimental : Dose Expansion Phase: Forimtamig + Carfilzomib
Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression. - Experimental : Dose Expansion Phase: Forimtamig + Daratumumab
Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.
- Study Type:
- Interventional
- Study Design:
- Allocation: Randomized
- Intervention Model: Sequential
- Primary Purpose: Treatment
- Masking: None
- Recruitment status:
- Recruiting
- Eligibility criteria:
-
usion Criteria:
-
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 12 weeks
* Documented diagnosis of MM according to the IMWG diagnostic criteria
* Evidence of progressive disease based on Investigator's determination of response by IMWG criteria on or after last dosing regimen
* Measurable disease
* AEs from prior anti-cancer therapy resolved to Grade ≤ 1,
* Adequate organ functions
-
* Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug
* Plasma cell leukemia with circulating plasma cell count ≥ 5% or >500/microliter (µL)
* Participants with known amyloidosis
* Participants with myelodysplastic syndrome
* Prior treatment with monoclonal antibody (mAb) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter
* Prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration
* Prior solid organ transplantation
* Active auto-immune disease or flare within 6 months prior to start of study treatment
* Known or suspected chronic active Epstein-Barr virus (EBV) infection
* Hepatitis B virus (HBV) infection
* Acute or chronic hepatitis C virus (HCV) infection
* Known history of HIV seropositivity
* Live vaccine(s) within one month prior to start of the treatment
* Participants not fully vaccinated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per local recommendations
* Previous refractoriness to carfilzomib
* Participants who discontinued prior carfilzomib treatment due to treatment-related toxicity
* Participants with known liver cirrhosis
* Participants eligible for allogeneic stem cell transplantation (SCT) or autologous SCT at the time of enrollment for Study BP43437 are excluded
- Locations / Centres:
-
Hamilton Health Sciences, Hamilton, Ontario – Recruiting
- Contacts:
- Name: Reference Study ID Number: BP43437 https://forpatients.roche.com/
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
- Publications:
- ???
- First posted:
- Not available
- Actual start date:
- 2023-12-12
- Last updated:
- 2024-07-04
- Estimated enrollment:
- 316
- Estimated completion date:
- 2027-06-10
- Estimated primary completion date:
- 2027-06-10
- Condition:
- Relapsed or Refractory Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-
- Accepts healthy volunteers:
- Not available
- Listed location countries:
- Not available
- NCT number:
- NCT06055075
- Other study ID numbers:
- BP43437
- Has Data monitoring committee:
- Not available
- U.S. FDA-regulated product:
- Yes
- IPD Sharing Statement :
- ???
- Responsible party:
-
Sponsor
- Study sponsor:
- lead_sponsor
Hoffmann-La Roche
Industry
- Collaborators:
- ???
- Investigators:
- Clinical Trials Hoffmann-La Roche
- Protocol Registration and Results System:
- ???
- Verification date:
- 2024-07-01