Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01832727 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

The primary objectives are as follows: Phase 1b: - To determine the maximum tolerated dose (MTD) of oprozomib given orally, once daily, on 2 different schedules. - To evaluate safety and tolerability Phase 2: - To estimate the overall response rate (ORR). - To evaluate safety and tolerability

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Claudia E. Paba-Prada, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Kathleen Colson, 617-632-6303, kathleen_colson@dfci.harvard.edu

Eligibility Criteria

INCLUSION 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. EXCLUSION CRITERIA: - 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 - Carfilzomib exposure within 6 months prior to first dose - 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
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