A randomized phase III study to compare Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) consolidation and Lenalidomide maintenance in patients with newly diagnosed multiple myeloma.

• Conditions: Multiple Myeloma; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 18.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2009-017903-28-CZ
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-26
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

- Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS (see appendix A), i.e. at least one of the CRAB criteria should be present;
- Measurable disease as defined by the presence of M-protein in serum or urine (serum Mproteïn > 10 g/l or urine M-proteïn > 200 mg/24 hours), or abnormal free light chain ratio;
- Age 18-65 years inclusive;
- WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by comorbid conditions) (see appendix D);
- Negative pregnancy test at inclusion if applicable;
- Written informed consent.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known intolerance of Boron;
- Systemic AL amyloidosis;
- Primary Plasmacell Leukemia;
- Non-secretory MM;
- Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 5 days for symptom control;
- Severe cardiac dysfunction (NYHA classification II-IV, see appendix E);
- Significant hepatic dysfunction (serum bilirubin ? 30 mmol/l or transaminases ? 2.5 times normal level), unless related to myeloma;
- Patients with GFR <15 ml/min,
- Patients known to be HIV-positive;
- Patients with active, uncontrolled infections;
-Patients with neuropathy, CTC grade 2 or higher;
-Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
- Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
- Lactating women.

Study & Design

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