A study of oprozomib, melphalan, and prednisone in patients newly diagnosed with multiple myeloma for whom transplants are not possible

Conditions: Multiple myeloma
MedDRA version: 16.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002125-27-GR

Lead Sponsor: Onyx Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 74

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:
a. Serum M-protein = 500 mg/dL
b. Urine M-protein = 200 mg/24 hour
c. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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 HIV, Hepatitis B virus and Hepatitis C virus infection (Exception: Subjects with chronic or cleared HBV and HCV infection and stable liver function tests [bilirubin, AST] will be allowed.
4. Significant neurotoxicity (Grade 2 with pain or higher) at the time of enrollment.
5. Plasma cell leukemia
6. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
7. Known amyloidosis