A Study of Oprozomib, Melphalan, and Prednisone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT02072863|
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : May 2, 2017
The purpose of Phase 1b of the study is to determine the maximum tolerated dose (MTD) of oprozomib in combination with melphalan and prednisone (OMP).
The purpose of Phase 2 of the study is to estimate the overall response rate (ORR) and complete response rate (CRR) of the OMP combination.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Oprozomib Drug: Melphalan Drug: Prednisone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b/2, Multicenter, Open-label Study of Oprozomib, Melphalan, and Prednisone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma|
|Study Start Date :||January 2014|
|Primary Completion Date :||January 2015|
|Study Completion Date :||September 2015|
U.S. FDA Resources
Experimental: Oprozomib with Melphalan and Prednisone (OMP)
Subjects will receive oprozomib administered orally.
The combination of oprozomib, melphalan, and prednisone (OMP) will be administered until progression of disease, unacceptable toxicity, discontinuation of study treatment for reasons other than progression or toxicity, or a maximum of 9 cycles (54 weeks), whichever occurs first.
Study subjects will receive oprozomib administered orally.Drug: Melphalan
Study subjects will receive melphalan 9 mg/m2.Drug: Prednisone
Study subjects will receive prednisone 60 mg/m2.
- Maximum Tolerated Dose (MTD) - Phase 1b [ Time Frame: 42 weeks ]MTD is defined as the highest dose at which a DLT is observed in less than 2 of 6 evaluable subjects occurring within the 4 weeks after the first dose of combination therapy.
- Overall Response Rate (ORR) - Phase 2 [ Time Frame: 39 months ]ORR defined as a best overall response of sCR, CR, VGPR, or PR according to the IMWG-URC.
- Complete Response Rate (CRR) - Phase 2 [ Time Frame: 39 months ]CRR defined as a best overall response of sCR or CR according to the IMWG-URC.
- Adverse Events (AEs) and Serious Adverse Events (SAEs) - Phase 2 [ Time Frame: Collected from signing of informed consent and throughout study until 30 days after the last dose of study treatment (up to 58 weeks) ]Adverse Events (AEs) and Serious Adverse Events (SAEs) graded according to the NCI-CTCAE (Version 4.03).
- Population Pharmacokinetic (PK) parameters - apparent clearance and volume of distribution [ Time Frame: 2 postdose time points in Cycle 1 Day 1, 1 predose and 2 postdose time points on Cycle 3 Day 1 and Cycle 5 Day 1 ]Evaluate population pharmacokinetic (PK) parameter estimates of oprozomib and variability in these estimates when administered in combination with melphalan and prednisone using a sparse sampling strategy and population-based analysis methodology.
- Duration of Response (DOR) [ Time Frame: 39 months ]Duration of Response (DOR) is defined as the time from evidence of PR or better to disease progression or death due to any cause.
- Progression-free Survival (PFS) [ Time Frame: 39 months ]Progression-free survival is defined as the time from the first day of study treatment (Cycle 1 Day 1) to the earlier of disease progression or death due to any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072863
|Department of Clinical Therapeutics, University of Athens|
|Athens, Attica, Greece|
|Ospedale Oncologico Regionale|
|Rionero in Vulture, Potenza, Italy|
|Azienda Ospedaliera Universitaria S Martino|
|AOU Maggiore della Carita, SCDU Heamatology|
|University of Rome|
|Hospital City of Health and Science of Turin, Hematology 1 Division|
|Vrijc Universiteit Medisch Centrum, Department of Hematology|
|Erasmus MC, Department of Hematology|