A Study of Oprozomib, Melphalan, and Prednisone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Oprozomib

Intervention Type DRUG

Study subjects will receive oprozomib administered orally.

Melphalan

Intervention Type DRUG

Study subjects will receive melphalan 9 mg/m2.

Prednisone

Intervention Type DRUG

Study subjects will receive prednisone 60 mg/m2.

Interventions

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Oprozomib

Study subjects will receive oprozomib administered orally.

Intervention Type DRUG

Melphalan

Study subjects will receive melphalan 9 mg/m2.

Intervention Type DRUG

Prednisone

Study subjects will receive prednisone 60 mg/m2.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Newly diagnosed symptomatic multiple myeloma patients who are transplant ineligible with measureable disease as indicated by one or more of the following:

1. Serum M-protein ≥ 500 mg/dL
2. Urine M-protein ≥ 200 mg/24 hour
3. Serum Free Light Chain: Involved free light chain (FLC) level ≥ 10 mg/dL, provided serum FLC ratio is abnormal
2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
3. Creatinine clearance (CrCl) ≥ 30 mL/min, either measured or calculated using the formula of Cockcroft and Gault \[(140 - age) × mass (kg) / (72 × serum creatinine mg/dL)\]. Multiply result by 0.85 if female.

Exclusion Criteria

1. 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 is allowed). Use of topical or inhaled steroids is acceptable.
2. Congestive heart failure (New York Hearth Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to first dose
3. Known or suspected HIV, active Hepatitis A, B C or virus infection (Exception: Subjects with chronic or cleared HBV and HCV infection and stable liver function tests \[bilirubin, AST\] will be allowed).
4. Significant neuropathy (Grade 2 with pain or higher) at the time of first dose.
5. Plasma cell leukemia.
6. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
7. Known amyloidosis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No