A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

Running, not enrolling · Phase 1

Conditions studied: Multiple Myeloma

In brief

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Key facts

Study ID: NCT04910568
Run by: Genentech, Inc.
People needed: 126
Starts: 2021-07-26
Expected to finish: 2028-12-21
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of at least 12 weeks
Agreement to provide bone marrow biopsy and aspirate samples
Resolution of adverse events from prior anti-cancer therapy to Grade <=1
Measurable disease
For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 5 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered
For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, during the treatment period, and for at least 2 months after the last dose of tocilizumab was administered to avoid exposing the embryo and sexual partner Additional Arm A-Specific Inclusion Criteria
Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies Additional Arm B-Specific Inclusion Criteria
For Cohort B1S: Participants with R/R MM who have received at least two prior lines of treatment, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
For Cohort B2S, B1E, B3E: Participants with R/R MM who have received at least one prior line of treatment that included at least two consecutive cycles of treatment, including a PI and an IMiD
For Cohort B4E: Participants with R/R MM who have received one to four lines of prior therapy that included at least two consecutive cycles of anti-CD38 therapy, lenalidomide and a PI, and either: Prior B-cell maturation antigen- (BCMA)-targeted therapy-directed chimeric antigen receptor T (CAR T) cell therapy or Prior BCMA-antibody-drug conjugate (ADC) therapy
Agreement to comply with all requirements of the pomalidomide pregnancy prevention program
For women of childbearing potential: agreement to remain abstinent or use two reliable methods of contraception starting at least 4 weeks prior to, during the treatment period, and for at least 4 weeks after the last dose of pomalidomide was administered
For men: agreement to remain abstinent or use a condom during the treatment period and for at least 4 weeks after the last dose of pomalidomide, (even if he has undergone a successful vasectomy) and agreement to refrain from donating sperm and blood during this same period Additional Arm C-Specific Inclusion Criteria
For Cohort C1S: Patients with R/R MM who have received at least two prior lines of treatment including a PI and an IMiD
For Cohort C2S and additional cohorts: Participants with R/R MM who have received at least 1 prior line of therapy
For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 102 days after the last dose of daratumumab was administered
For men: agreement to remain abstinent or use a condom during the treatment period and for at least 102 days after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period

You may not qualify if…

Prior treatment with cevostamab or another agent targeting FcRH5
Inability to comply with protocol-mandated hospitalization and activities restrictions
Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable).
Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
Prior treatment with systemic immunotherapeutic agents, including, but not limited to, cytokine therapy and anti-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment
Prior treatment with CAR T-cell therapy within 12 weeks before first study treatment
Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focal radiation) prior to first study treatment
Treatment with any chemotherapeutic agent or other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
Autologous SCT within 100 days prior to first study treatment
Prior allogeneic stem cell transplant(ation) (SCT)
Circulating plasma cell count exceeding 500/micro L or 5% of the peripheral blood white cells
Prior solid organ transplantation
History of autoimmune disease
History of confirmed progressive multifocal leukoencephalopathy
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Known history of amyloidosis
Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
History of other malignancy within 2 years prior to screening
Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
Significant cardiovascular disease
Symptomatic active pulmonary disease or requiring supplemental oxygen
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
Known or suspected chronic active Epstein-Barr virus (EBV) infection
Recent major surgery within 4 weeks prior to first study treatment

Where it is running

City of Hope — Duarte, California, United States
City of Hope - Lennar Foundation Cancer Center — Irvine, California, United States
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center — Denver, Colorado, United States
Karmanos Cancer Institute. — Detroit, Michigan, United States
Washington University School of Medicine — St Louis, Missouri, United States
Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
The Alfred Hospital — Melbourne, Victoria, Australia
Cross Cancer Institute — Edmonton, Alberta, Canada
Hamilton Health Sciences — Hamilton, Ontario, Canada
University Health Network — Toronto, Ontario, Canada
Fakultni Nemocnice Ostrava — Ostrava, Czechia
Rigshospitalet — København Ø, Denmark
CHU de Poitiers - La Miletrie — Poitiers, France
Rambam Medical Center — Haifa, Israel
Asst Papa Giovanni Xxiii — Bergamo, Lombardy, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili — Brescia, Lombardy, Italy
Yamagata University Hospital — Yamagata, Japan
Pratia Onkologia Katowice — Katowice, Poland
Seoul National University Hospital — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Hospital General Universitario Gregorio Marañon — Madrid, Spain
University College London Hospitals NHS Foundation Trust — London, United Kingdom
Royal Marsden Hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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