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Multiple Myeloma

Oprozomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma (2723)
Phase 1b/2, Multicenter, Open-label Study of Oprozomib, Lenalidomide, and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma
Status Conditions Phase Study ID
Recruiting Multiple Myeloma Phase I/II 2723.00
NCT01881789
Summary
Purpose
Phase 1b:
  • To establish the maximum tolerated dose (MTD) of oprozomib administered orally in combination with lenalidomide and dexamethasone.
Phase 2:
  • To estimate the overall response rate (ORR) and complete response rate (CRR) 
Secondary Objectives:
  • 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)

Investigator
Bill Bensinger, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
December 24, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.