|Recruiting||Multiple Myeloma||Phase I/II||
- To establish the maximum tolerated dose (MTD) of oprozomib administered orally in combination with lenalidomide and dexamethasone.
- To estimate the overall response rate (ORR) and complete response rate (CRR)
- To evaluate the safety and tolerability of oprozomib administered in combination with lenalidomide and dexamethasone
- To evaluate population pharmacokinetic (PK) parameter estimates of oprozomib and variability in these estimates when administered in combination with lenalidomide and dexamethasone
- To estimate the duration of response (DOR)
- To estimate progression-free survival (PFS)
- Newly diagnosed, symptomatic multiple myeloma patients for whom a hematopoietic stem cell transplant is not planned or scheduled during the study or are considered ineligible for hematopoietic stem cell transplant, with measurable disease
- Any prior antimyeloma therapy except oral steroids (dexamethasone up to a total dose of 160 mg or equivalent within 14 days prior to the first dose of study treatment). Use of topical or inhaled steroids is acceptable.
- Major surgery within 3 weeks prior to first dose
- Active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of 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 with Gleason Score 6 or less with stable prostate specific antigen levels, or cancer considered cured by surgical resection
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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