A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma

Sponsor
Hoffmann-La Roche
Study ID
NCT05583617
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cevostamab — DRUG
    Substudy 2: Cevostamab will be administered intravenously (IV) on a 28-day cycle, up to a total of 13 cycles. Substudy 4: Cevostamab will be administered by IV on a 21-day cycle, up to a total of 17 cycles.
  • Lenalidomide — DRUG
    Lenalidomide will be administered PO on days 1-21 of a 28-day cycle.
  • Tocilizumab — DRUG
    Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
  • Iberdomide — DRUG
    Iberdomide will be administered PO on days 1-14 of a 21-day cycle.
  • Dexamethasone — DRUG
    Dexamethasone will be administered on Days 2 and 8 of Cycles 1-3.

Study Details

CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.

Key Dates

Start date
Nov 14, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 2: Dose Escalation and Expansion
    In the pre-phase, participants will receive 2 step-up doses and a target dose of cevostamab. The step-up dose will be given on Day(D)1 and D4. The target dose will be given on D8. Subsequently the target dose will be administered on D1 and D15 for cycles 1-6 and D1 of cycle 7 onwards. Each cycle is 28 days. Lenalidomide will be administered by mouth (PO) on a 28-day cycle. During the dose expansion phase, cevostamab will be administered following the same dosing schedule as the dose escalation phase. The target dose will be determined after the escalation phase. Lenalidomide will be administered PO on a 28-day cycle. Enrollment for Substudy 2 has closed.
  • Experimental: Substudy 4: Dose Escalation and Expansion
    In the pre-phase, participants will receive 2 step-up doses and a target dose of cevostamab. The step-up dose will be given on D1 and D4. The target dose will be given on D8. Subsequently the target dose will be administered on D1 of each cycle, every 3 weeks (Q3W). Each cycle is 21 days. Iberdomide will be administered PO on a 21-day cycle. During the dose expansion phase, cevostamab will be administered following the same dosing schedule as the dose escalation phase. The target dose will be determined after the escalation phase. Iberdomide will be administered PO on a 21-day cycle.

Primary Outcome Measure

Stage 1: Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to approximately 5 years ]

Central Contacts

  • Reference Study ID Number: CO43923 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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