Terminated/Withdrawn
Sponsor ID
OPZ003

Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma

Sponsor ID
OPZ003
Clinicaltrials.gov ID
NCT01881789
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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 with cyclophosphamide and dexamethasone (OCyd)

• To evaluate the safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide

Phase 2:

• To estimate the antitumor activity of each combination regimen, as measured by overall response rate (ORR) and complete response rate (CRR)

• To evaluate the safety and tolerability of each combination regimens, as assessed by the type, incidence, severity and seriousness of adverse events, and abnormalities in selected laboratory analytes

Additional Study Details

Phase
Phase 1/Phase 2
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
22
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Tolerated Dose (MTD)

Timeframe: 6 months

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 36 months

Overall Response Rate (ORR)

Timeframe: 14 months

Complete Response Rate (CRR)

Timeframe: 17 months

Secondary Outcome Measures

Population Pharmacokinetic (PK) Parameters - Apparent Clearance

Timeframe: 18 months

Population Pharmacokinetic (PK) Parameters - Volume of Distribution

Timeframe: 18 months

Duration of Response (DOR)

Timeframe: 42 months

Progression-Free Survival (PFS)

Timeframe: 42 months

Locations

Location
Status
Contact Us
Location
Providence St. Joseph’s Hospital
Burbank, CA, United States
Status
Recruiting
Location
Fred Hutchinson Cancer Research Center
Seattle, WA, United States
Status
Recruiting
Location
Colorado Blood Cancer Institute
Denver, CO, United States
Status
Recruiting
Location
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, WI, United States
Status
Recruiting
Location
University of Texas M.D. Anderson Cancer Center
Houston, TX, United States
Status
Recruiting
Location
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, IN, United States
Status
Recruiting
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