A phase III trial comparing bortezomib, cyclophosphamide and dexamethasone versus lenalinomide cyclophosphamide and dexamethasone in patients with multiple myeloma at first relapse - MM-Rel

Phase 1

• Conditions: Multiple mieloma; MedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021557-40-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-14
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age between 18 and 75 years old ; • written informed consent; • multiple myeloma at first active relapse; • Karnofsky performance status > 60%; • measurable disease: secretory MM defined as a serum monoclonal IgG of >= 1 g/dL or serum monoclonal IgA, IgD or IgE >= 0.5 g/dL or urine light-chain excretion of >200 mg/24 hours; • absolute neutrophil count >= 1000/microl, platelets > 75.000/microl; • no severe organ disfunctions; • life expectancy > 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
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

• central nervous system localization; • pulmonary embolism in the last 3 months; • ongoing maintenance treatment with lenalinomide; • previous exposure to bortezomib and/or lenalidomide in the first line treatment, unless the patient has obtained at least a response >PR extended for >12 months; • grade 3-4 peripheral neuropathy; • any active, uncontrolled infection; • positive serologic markers for human immunodeficiency virus (HIV), active hepatitis B virus (HBV DNA positivity), and hepatitis C virus (HCV RNA positivity) infection; • Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study; • uncontrolled diabetes mellitus; • serum bilirubin levels > 2 the upper normal limit; • clearance of creatinine < 30 ml/min; • DLCO < 50%; • ejection fraction < 45% (or myocardial infarction in the last 12 months); • pregnancy or lactation; • patient not agreeing to take adequate contraceptive measures during the study, if at risk; • psychiatric disease; • active secondary malignancy; • inability to comply with medical therapy or follow-up.

Study & Design

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