Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma. - CARMYSAP

• Conditions: elderly untreated patients with multiple myeloma.; MedDRA version: 12.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2010-019462-92-FR
• Lead Sponsor: CHU de Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-13
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.
1.Must understand and voluntarily sign an informed consent form
2.Age > 65 years at the time of signing consent
3.Previously untreated, symptomatic multiple myeloma as defined by the 2 criteria below:
•MM diagnostic criteria (all 3 required):
oMonoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy-proven plasmacytoma
oMonoclonal protein present in the serum and/or urine
oMyeloma-related organ dysfunction (at least one of the following)
[C] Calcium elevation in the blood (serum calcium >10.5 mg/L or upper limit of normal)
[R] Renal insufficiency (serum creatinine >2 mg/dL)
[A] Anemia (hemoglobin <10 g/dL or 2 g < normal)
[B] Lytic bone lesions or osteoporosis
AND have measurable disease by protein electrophoresis analyses as defined by the following:
•IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ? 0.5 g/dL or urine M-protein level 200 mg/24 hours
•IgA multiple myeloma: Serum M-protein level ? 0.5 mg/dL or urine M-protein level 200 mg/24 hours
•IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
•IgD multiple myeloma: Serum M-protein level ? 0.05 g/dL or urine M-protein level 200 mg/24 hours
•Light chain multiple myeloma: Patients with serum free light chain disease in whom the involved light chain measures = 10 mg/dL
4.ECOG performance status of 0, 1, or 2
5.Able to adhere to the study visit schedule and other protocol requirements
6.Life-expectancy > 3 months
7.Affiliation number to National Health Care System
8.Karnofsky performance status (KPS) of at least 60%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting any of the following exclusion criteria are not eligible to enroll in this study.
1.Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days (4 weeks) of consent
2.Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study.
3.Any of the following laboratory abnormalities
•Absolute neutrophil count (ANC) < 1,000 cells/?L (1.0 x 109/L)
•Platelet count < 50,000 cells/?L (50 × 109/L) for patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count < 30,000/?L for patients in whom ? 50% of bone marrow nucleated cells are plasma cells
•Serum SGPT/ALT > 3.0× upper limit of normal (ULN); Bilirubin >2× ULN [ALT more specific to liver]
•Creatinine clearance = 30 mL/min (Cockcroft-Gault calculation)
4.Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ? 3 years. Exceptions include the following:
•Basal cell carcinoma of the skin
•Squamous cell carcinoma of the skin
•Carcinoma in situ of the cervix
•Carcinoma in situ of the breast
•Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
5.Peripheral neuropathy of > grade 2 severity.
6.Myocardial infarction within 3 months of enrollment, unstable angina within 2 months or New York Heart Association class III or IV heart failure.
7.Known HIV positivity or active infectious hepatitis, type A, B, or C.
8.Female of childbearing potential
9.Oral or IV fluid hydration contraindicated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified