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

Phase 3

Recruiting

Conditions: 10035227
Multiple Myeloma

Registration Number: NL-OMON54491

Lead Sponsor: HOVO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 356

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 M-proteïn > 10
g/l or urine M-proteïn > 200 mg/24 hours) or abnormal free light chain ratio
with involved free light chain (FLC) > 100 mg/l or proven plasmacytoma by
biopsy, - Age 18-65 years inclusive;, - WHO performance status 0-3 (WHO=3 is
allowed only when caused by MM and not by co-morbid conditions) , - Negative
pregnancy test at inclusion if applicable;, - Written informed consent.

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- For all registered patients: progression free survival (PFS) as defined by<br /><br>time from registration to progression or death from any cause whichever occurs<br /><br>first).<br /><br>- For all patients included in R1; PFS as defined by time from randomization R1<br /><br>to progression or death from any cause whichever comes first<br /><br>- For all patients included in R2; PFS as defined by time from randomization R2<br /><br>to progression or death from any cause whichever comes first</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Response (PR, VGPR, CR and stringent CR), and improvement of response during<br /><br>the various stages of the treatment<br /><br>- Overall survival measured from the time of registration/randomization R !/<br /><br>randomization R2.<br /><br>- Toxicity<br /><br>- Quality of life defined by the EORTC QLQ-C30 and QLQ-MY20 definitions.</p><br>

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