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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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ClinicalTrials.gov Identifier: NCT06055075
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : May 13, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: Forimtamig Drug: Carfilzomib Drug: Daratumumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 12, 2023
Estimated Primary Completion Date : June 10, 2027
Estimated Study Completion Date : June 10, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.
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.
 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.
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.
 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: Daratumumab
Daratumumab will be administered via SC injection in combination with forimtamig.
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.
 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: Daratumumab
Daratumumab will be administered via SC injection in combination with forimtamig.
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.
 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: Daratumumab
Daratumumab will be administered via SC injection in combination with forimtamig.
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.
 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.
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.
 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.
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.
 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: Daratumumab
Daratumumab will be administered via SC injection in combination with forimtamig.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]
  2. Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria [ Time Frame: Up to approximately 24 months ]
  3. Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria [ Time Frame: Up to approximately 24 months ]
  4. Rate of Very Good Partial Response (VGPR) or Better as Determined by the Investigator per IMWG Criteria [ Time Frame: Up to approximately 24 months ]

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) as Determined by the Investigator per IMWG Criteria [ Time Frame: Up to approximately 24 months ]
  2. Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria [ Time Frame: Up to approximately 24 months ]
  3. Time to First Response as Determined by the Investigator per IMWG Criteria [ Time Frame: Up to approximately 24 months ]
  4. Time to Best Response as Determined by the Investigator per IMWG Criteria [ Time Frame: Up to approximately 24 months ]
  5. Overall Survival (OS) as Determined by the Investigator per IMWG Criteria [ Time Frame: Up to approximately 24 months ]
  6. Serum Concentration of Forimtamig [ Time Frame: Up to approximately 24 months ]
  7. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig [ Time Frame: Up to approximately 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06055075


Contacts
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Contact: Reference Study ID Number: BP43437 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT06055075    
Other Study ID Numbers: BP43437
2023-503689-21-00 ( Other Identifier: EU Trial Number )
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: May 13, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Daratumumab
Antineoplastic Agents