Multiple Myeloma Clinical Trial

Dose-Escalation Study of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Summary

This is a phase I, multicenter, open-label, dose-escalation study of cevostamab administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).

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
Participants must have relapsed or refractory (R/R) multiple myeloma (MM) for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
Adverse events from prior anti-cancer therapy resolved to Grade < or = 1, except any grade alopecia and/or peripheral sensory or motor neuropathy which must have resolved to Grade < or = 2
Measurable disease defined by laboratory test results
Female participants of childbearing age must agree to remain abstinent or use reliable contraceptive methods during the treatment period, and at least 5 months after last dose of study drug. Women must refrain from breastfeeding during the same period.
Male participants must agree to refrain from donating sperm, to abstain or use a condom during the treatment period, and for at least 2 months after the last dose of tocilizumab (if applicable).

Exclusion Criteria:

Inability to comply with protocol-mandated hospitalization and activities restrictions
Pregnant or breastfeeding, or planning 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 of tocilizumab (if applicable)
Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate as anti-cancer therapy within 4 weeks before first infusion
Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first infusion
Prior treatment with chimeric antigen receptor (CAR) T-cell therapy within 12 weeks before first cevostamab infusion
Known treatment-related, immune-mediated adverse events associated with prior immunotherapeutic agents
Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first cevostamab infusion
Autologous stem cell transplantation (SCT) within 100 days prior to first infusion
Prior allogeneic SCT or solid organ transplantation
Absolute plasma cell count exceeding 500/micro L or 5% of the peripheral blood white cells
History of autoimmune disease or of confirmed progressive multifocal leukoencephalopathy
Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Patients with known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy)
Patients with lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
History of other malignancy that could affect compliance with the protocol or interpretation of results
Current or past history of central nervous system (CNS) disease, or CNS involvement by MM
Significant cardiovascular disease that may limit a patient's ability to adequately respond to a CRS event
Symptomatic active pulmonary disease requiring supplemental oxygen
Within 14 days prior to first cevostamab infusion: known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks prior to first infusion
Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or cytomegalovirus (CMV) PCR prior to first study treatment
Known or suspected chronic active EBV infection, acute or chronic hepatitis C virus (HCV) infection
Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
Recent major surgery within 4 weeks prior to first infusion
Human Immunodeficiency Virus (HIV) positive
Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days, prior to first study treatment
Administration of a live, attenuated vaccine within 4 weeks before first cevostamab infusion or anticipation that such a live attenuated vaccine will be required during the study
Received systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), with the exception of corticosteroid treatment <=10 mg/day prednisone or equivalent within 2 weeks prior to first dose of cevostamab and, if applicable, tocilizumab premedication prior to first dose of cevostamab
History of illicit drug or alcohol abuse within 12 months prior to screening
Any medical condition or laboratory test abnormality that precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

420

Study ID:

NCT03275103

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 18 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Mayo Clinic Hospital - Arizona
Scottsdale Arizona, 85259, United States
City of Hope
Duarte California, 91010, United States
University of California San Francisco
San Francisco California, 94117, United States
University of Colorado Denver
Aurora Colorado, 80045, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Mount Sinai Hospital
New York New York, 10029, United States
Memorial Sloan Kettering
New York New York, 10065, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Tennessee Oncology - Nashville
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Alfred Hospital
Melbourne Victoria, 3004, Australia
Peter MacCallum Cancer Center
North Melbourne Victoria, 3051, Australia
University of Calgary
Calgary Alberta, T2N 2, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca , 37007, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

420

Study ID:

NCT03275103

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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