Pharmacogenomic study to predict survival, best response and toxicity in newly diagnosed myeloma patients who are either 65 years of age or older treated with either a combination of melphalan-prednisone-thalidomide or lenalidomide-dexamethasone

Phase 1

• Conditions: Patients aged 65 and over, suffering of previously untreated symptomatic multiple myeloma; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2008-003486-58-BE
• Lead Sponsor: Intergroupe Francophone du Myélome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-18
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

In order to participate in this study protocol, patients must fulfill the following conditions:
- Must understand and voluntarily sign and informed consent form
- Age = 65 years at the time of signing consent
- Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all 3 required):
? Monoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy-proven plasmacytoma
? Monoclonal protein present in the serum and/or urine
? Myeloma-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
- Have measurable disease by protein electrophoresis analyses as defined by the following:
? IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
? IgA multiple myeloma: Serum M-protein level ³ 0.5 mg/dL or urine M-protein level ³ 200 mg/24 hours
? IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level = 1.0g/dL or urine M-protein level = 200mg/24hours
? IgD multiple myeloma: Serum M-protein level = 0.05 g/dL or urine M-protein level = 200 mg/24 hours
? Light chain multiple myeloma: Serum M-protein level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
- ECOG performance status of 0, 1, or 2
- Treated by either melphalan-prednisone-thalidomide or lenalidomide-dexamethasone

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

- 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 randomization]
- Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study
- Any of the following laboratory abnormalities:
? Absolute neutrophil count (ANC) < 1,000 cells/µL (1.0 x 109/L)
? Platelet count < 50,000 cells/µL (50 x 109/L) for patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/µL for patients in whom = 50% of bone marrow nucleated cells are plasma cells
? Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
? Creatinine clearance = 30 mL/min (Cockroft-Gault calculation)
- 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)
- Patients who have are unable or unwilling to undergo antithrombotic therapy
- Peripheral neuropathy of > grade 2 severity
- Known HIV positivity or active infectious hepatitis, type A, B, or C.
- Primary AL amyloidosis and myeloma complicated by amyloidosis.
- Renal failure requiring dialysis

Study & Design

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