16M-14-1: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma
Description
Detailed Description
Multiple myeloma is a type of blood cancer caused by the transformation and uncontrolled multiplication of plasma cells (a type pf blood cell). It is the second most common hematological malignancy and is invariably fatal. Myeloma cells expand in the bone marrow causing skeletal destruction, high calcium levels, kidney failure and anemia.
The study population will consist of multiple myeloma patients requiring therapy who have relapsed and/or are refractory to their last therapy and have been treated with at least 1, but not more than 5 lines of multiple myeloma therapy.
The study drug, oprozomib works by preventing the breakdown of certain proteins in cells, causing the cells to die. Studies with oprozomib have been able to demonstrate the treatment potential for blocking proteasomes (protein complexes) in multiple myeloma. These proteasomes main function is to degrade unneeded or damaged proteins.
The primary objective of Phase 2 is to estimate the overall response rate.
This study is an open-label, Phase 1b/2, multicenter study in which participants will receive oprozomib administered orally, once daily, in combination with dexamethasone as follows:
Days 1, 2, 8, and 9 of a 14-day cycle;
Treatment will be administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
USC will only participate in Phase 2. The Phase 2 portion of this study will be initiated at the sponsors discretion using the recommended dose determined from 1 or both dosing schedules. The total study duration is expected to be approximately 26 months.
Phase
Phase 1/2 - for trials that are a combination of phases 1 and 2.Inclusion and Exclusion Criteria
- - Diagnosis of multiple myeloma with measureable disease - Patients requiring therapy who have relapsed and/or are refractory to their last therapy and have been treated with at least 1, but not more than 5 lines of multiple myeloma therapy. - Prior carfizolmib is not required but is allowed if a patient had at least 2 cycles of carfilzomib alone or in combination with a dose of at least 20/27 mg/m2, as long as the patient :
- Had at least a partial response to prior carfilzomib therapy
- Was not removed from carfilzomib therapy due to toxicity, unless approved by the medical monitor
- Was not removed from carfilzomib therapy for progressive disease nor experienced progressive disease within 6 months after any prior carfizolmib therapy
- Radiation therapy within 2 weeks prior to first dose. Localized radiation therapy within 1 week prior to first dose.
- Immunotherapy/standard myeloma therapy within 2 weeks; prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks)
- Participation in an investigational therapeutic study within 3 weeks prior to first dose
- Patients who failed to respond to carfilzomib treatment defined as not having achieved ≥ PR during therapy
- Prior oprozomib exposure
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
- Other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma of the skin, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer of Gleason Score 6 or less with stable prostate specific antigen levels, or cancer considered cured by surgical resection.
- Plasma cell leukemia
Sites
Please contact Poornima Murali to learn more about where you can participate in this trial. Please use the contact form on the right side.
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