Status:
TERMINATED
Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Amgen
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objectives of this study included the following: Phase 1b: * To establish the maximum tolerated dose (MTD) of oprozomib given in combination with lenalidomide and dexamethasone (ORd) or ...
Detailed Description
Phase 1b used a standard 3 + 3 dose-escalation scheme to determine the MTD. For each combination regimen, oprozomib doses were to be escalated in sequential cohorts of 3 participants with expansion to...
Eligibility Criteria
Inclusion
- Key
- Newly diagnosed, symptomatic multiple myeloma patients for whom treatment is indicated per the National Comprehensive Cancer Network (NCCN) guidelines, and 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
- Creatinine clearance of ≥ 50 mL/min (measured or calculated using the Cockcroft and Gault formula)
- Key
Exclusion
- Any prior systemic 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
- Radiation therapy within 2 weeks prior to first dose
- Major surgery within 3 weeks prior to first dose
- Active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose
- Clinical significant gastrointestinal bleeding in the 6 months prior to Cycle 1 Day 1 (C1D1) 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 except those considered cured by surgical resection including some cases of: with the exception of adequately treated basal or squamous cell carcinoma of the skin, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the breast or 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
Key Trial Info
Start Date :
October 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01881789
Start Date
October 28 2013
End Date
September 23 2019
Last Update
November 14 2022
Active Locations (14)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States
2
Providence St. Joseph's Hospital
Burbank, California, United States
3
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
4
Monterey Bay Oncology Corp DBA Pacific Cancer Care
Salinas, California, United States