MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

Titre officiel

A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA

Sommaire:

The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.

Description de l'essai

Primary Outcome:

• Sub-Study A Phase 1: Dose Limiting Toxicity
• Sub-Study A Phase 2: Objective Response Rate
• Sub-Study B Phase 1 Escalation: Dose Limiting Toxicity
• Sub-Study B Phase 1 Expansion: Frequency of Treatment-Emergent Adverse Events
• Sub-Study B Phase 1 Expansion: Frequency of Laboratory Abnormalities

• Sub-Study A Phase 1: Objective Response Rate
• Sub-Study A Phase 1 and Phase 2: Complete Response Rate
• Sub-Study A Phase 1 and Phase 2: Time to Response
• Sub-Study A Phase 1 and 2: Duration of Response
• Sub-Study A Phase 1 and Phase 2: Duration of Complete Response
• Sub-Study A Phase 1 and Phase 2: Progression Free Survival
• Sub-Study A Phase 1 and Phase 2: Overall Survival
• Sub-Study A Phase 1 and Phase 2: Minimal Residual Disease Negativity Rate
• Sub-Study A Phase 1 and Phase 2: Frequency of Treatment-Emergent Adverse Events
• Sub-Study A Phase 1 and Phase 2: Frequency of Laboratory Abnormalities
• Sub-Study A Phase 1 and Phase 2: Immunogenicity of elranatamab in combination with nirogacestat
• Sub-Study A Phase 1 and Phase 2: Concentrations of elranatamab and/or nirogacestat
• Sub-Study A Phase 1: Maximum Observed Concentration (Cmax) for elranatamab
• Sub-Study A Phase 1: Time to Maximum Concentration (Tmax) for elranatamab
• Sub-Study A Phase 1: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab
• Sub-Study B Phase 1 Escalation: Frequency of Treatment-Emergent Adverse Events
• Sub-Study B Phase 1 Escalation: Frequency of Laboratory Abnormalities
• Sub-Study B Phase 1 Escalation and Expansion: Objective Response Rate
• Sub-Study B Phase 1 Escalation and Expansion: Complete Response Rate
• Sub-Study B Phase 1 Escalation and Expansion: Time to Response
• Sub-Study B Phase 1 Escalation and Expansion: Duration of Response
• Sub-Study B Phase 1 Escalation and Expansion: Duration of Complete Response
• Sub-Study B Phase 1 Escalation and Expansion: Progression Free Survival
• Sub-Study B Phase 1 Escalation and Expansion: Overall Survival
• Sub-Study B Phase 1 Escalation and Expansion: Minimal Residual Disease Negativity Rate
• Sub-Study B Phase 1 Escalation and Expansion: Immunogenicity of elranatamab in combination with lenalidomide
• Sub-Study B Phase 1 Escalation and Expansion: Concentrations of elranatamab and/or lenalidomide
• Sub-Study B Phase 1 Escalation and Expansion: Maximum Observed Concentrations (Cmax) for elranatamab
• Sub-Study B Phase 1 Escalation and Expansion: Time to Maximum Concentration (Tmax) for elranatamab
• Sub-Study B Phase 1 Escalation and Expansion: Area Under the Concentration versus Time Curve from Time 0 to the Last Measurable Concentration (AUClast) for elranatamab

Voir cet essai sur ClinicalTrials.gov