Multiple Myeloma Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
For Cohort B1E and additional cohorts: Participants with R/R MM who have received at least 1 prior line of treatment
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: Participants with R/R MM who have received at least two prior lines of treatment
For Cohort C1E 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

Exclusion Criteria:

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 chimeric antigen receptor T (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
Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
Acute or chronic hepatitis C virus (HCV) infection
Known history of Grade >= 3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies
Known history of HIV seropositivity
Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study
Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment <=10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment
History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment Additional Arm B-Specific Exclusion Criteria
Pregnant or breastfeeding, or intending to become pregnant 4 weeks prior to initiation of study treatment, during the study, (including treatment interruptions) or within 4 weeks after the last dose of pomalidomide
Significant cardiovascular disease (such as, but not limited to, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 12 months, uncontrolled arrhythmias, or unstable angina)
History of erythema multiforme, Grade >=3 rash, blistering, or severe hypersensitivity to prior treatment with immunomodulatory drugs such as thalidomide, lenalidomide, or pomalidomide
Inability to tolerate thromboprophylaxis, or contraindication to thromboprophylaxis
GI disease that might significantly alter absorption of oral drugs Additional Arm C-Specific Exclusion Criteria
Pregnant or breastfeeding, or intending to become pregnant during the study or within 102 days after the last dose of daratumumab
Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of daratumumab formulations
Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal
Known moderate or severe persistent asthma within the past 2 years, or current uncontrolled asthma of any classification

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

170

Study ID:

NCT04910568

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 12 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver Colorado, 80218, United States
Winship Cancer Institute
Atlanta Georgia, 30322, United States
Karmanos Cancer Institute.
Detroit Michigan, 48201, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Peter MacCallum Cancer Centre; Department of Haematology
Melbourne Victoria, 3002, Australia
The Alfred Hospital; Malignant Haematology & Stem Cell Transplant Service
Melbourne Victoria, 3004, Australia
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto Ontario, M5G 2, Canada
Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
Ostrava , 708 5, Czechia
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia Lombardia, 25123, Italy
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

170

Study ID:

NCT04910568

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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