Cevostamab for Multiple Myeloma
(CAMMA 1 Trial)

Recruiting in Palo Alto (17 mi)

+51 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called cevostamab alone and with other drugs to help patients with multiple myeloma that has come back or not responded to treatment. The drug aims to help the immune system kill cancer cells.

Eligibility Criteria

This trial is for adults with relapsed or refractory Multiple Myeloma who have tried other treatments without success or cannot tolerate them. Participants must be willing to provide bone marrow samples, use contraception, and have a life expectancy of at least 12 weeks. They should not have had certain recent treatments, autoimmune diseases, major surgery, severe heart conditions, or specific allergies.

Inclusion Criteria

My multiple myeloma has returned or is resistant, and I can't tolerate or use standard treatments.

You have a disease that can be measured or seen on tests or scans.

I agree to use contraception or remain abstinent and not donate sperm or blood while on pomalidomide and for 4 weeks after.

+14 more

Exclusion Criteria

I have had a stem cell transplant from a donor.

I haven't taken strong immune-suppressing drugs, except for low-dose steroids, in the last 2 weeks.

I need extra oxygen or have trouble breathing due to lung problems.

+40 more

Participant Groups

The study tests Cevostamab alone or combined with Pomalidomide and Dexamethasone (Pd) or Daratumumab and Dexamethasone (Dd). It's an open-label Phase Ib trial where participants receive these drugs through IV infusion to assess safety, tolerability, how the body processes the drug (PK), and how it works in the body (PD).

3Treatment groups

Experimental Treatment

Group I: Single-Agent Cevostamab (Arm A)Experimental Treatment3 Interventions

Cohort A1S is a safety run-in arm evaluating cevostamab administered in 28-day cycles on a modified weekly schedule. Cohort A1E, an expansion cohort, has been opened and finished enrolling participants. Participants will be treated with single-agent cevostamab administered in 28-day cycles on a modified weekly schedule.

Group II: Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B)Experimental Treatment4 Interventions

Participants will be treated with cevostamab monotherapy during a 14-day period prior to the start of pomalidomide treatment (cevostamab pre-phase). Cohort B1S is a safety run-in arm evaluating cevostamab and Pd administered in 28-day cycles every 2 weeks (Q2W) followed by every 4 weeks (Q4W) schedule. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts. Two target dose levels of target dose level 1 (DL1) and lower dose level -1 (DL-1) of cevostamab will be selected for randomization in expansion cohorts. Expansion cohorts will follow the same Q2W/Q4W dosing schedule as Cohort B1S.

Group III: Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C)Experimental Treatment4 Interventions

Cohort C1S is a safety run-in arm evaluating cevostamab and Dd administered in 21 day cycles from Cycle(C)1 - C8 every 3 weeks (Q3W) and 28-day cycles from C9 onwards Q4W. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts. Two target dose levels of DL1 and DL-1 of cevostamab will be selected for randomization in expansion cohorts. Expansion cohorts will follow the same Q3W/Q4W dosing schedule as Cohort C1S.