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A study to find out if a new medicine (RO7297089) is safe and effective for people with cancer (multiple myeloma)
A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Cancer Multiple Myeloma
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1
Trial Identifier
NCT04434469, GO41582
Condition
Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Official Title
An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Study Summary
This clinical trial was done to study a new medicine, called, “RO7297089”, for the treatment of patients with “multiple myeloma”. Researchers wanted to find out how safe was it to give people different doses of the study medicine. Researchers also wanted to learn how much medicine was available in the body at different time points with different doses, and if cancer responded to the medicine. Twenty-seven people with multiple myeloma took part in this study at 10 study centers in 4 countries.
Eligibility Criteria
All
≥18 Years
No
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
- Measurable disease
Exclusion Criteria
- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer within 4 weeks before first RO7297089 infusion
- Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
- Prior treatment with CAR-T therapy within 90 days before first study drug administration
- Treatment with 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 RO7297089 infusion
- Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
- Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
- Primary or secondary plasma cell leukemia
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
- Significant cardiovascular disease
- Current CNS involvement by MM
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com