Study phase: phase III Study objective: * Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT) * Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no consolidation * Comparison of single versus tandem high dose Melphalan with ASCT Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS stages 1-3, age 18-65 years inclusive Study design: Prospective, multicenter, intergroup, randomized Duration of treatment: Expected duration of induction, stem cell collection and intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance therapy with Lenalidomide will be given until relapse. All patients will be followed until 10 years after registration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,503
* Bortezomib \_ 1.3 mg/m2 \_ i.v. rapid infusion \_ days 1,4,8,11,22,25,29,32 * Melphalan \_ 9 mg/m² \_ p.o. \_ days 1-4 * Prednisone \_ 60 mg/m² \_ p.o. \_ days 1-4
\- Melphalan \_ 100 mg/m² \_ i.v. rapid infusion \_ -3, -2\* \*Patients with renal insufficiency 100 mg/m2 only at day -3 If a patient is randomized to receive 2 x HDM a second course of High Dose Melphalan may be administered between 2 and 3 months after the first course when the patient achieved at least PR.
* Bortezomib \_ 1.3 mg/m2 \_ i.v. rapid infusion \_ days 1,4,8,11 * Lenalidomide \_ 25 mg \_ p.o. \_ days 1-21 * Dexamethasone \_ 20 mg \_ p.o. \_ days 1,2,4,5,8,9,11,12
AU-Brisbane-PAH
Brisbane, Australia
AU-Canberra-CANBERRAHOSPITAL
Canberra, Australia
AU-Melbourne-ALFRED
Melbourne, Australia
AU-Sydney-CONCORD
Sydney, Australia
AU-Sydney-NEPEAN
Sydney, Australia
Prince of Wales Hospital
Sydney, Australia
For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).
For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).
Time frame: end of trial (last patient last visit)
For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first
For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first
Time frame: end of trial (last patient last visit)
For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first
For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first
Time frame: end of trial (last patient last visit)
Overall survival measured from the time of registration /randomization R1/ randomization R2. Patients still alive or lost to follow up are censored at the date they were last known to be alive.
Overall survival measured from the time of registration /randomization R1/ randomization R2. Patients still alive or lost to follow up are censored at the date they were last known to be alive.
Time frame: end of trial (last patient last visit)
Toxicity
Toxicity
Time frame: End of trial (last patient last visit)
Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.
Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.
Time frame: end of trial (last patient last visit)
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St George Hospital
Sydney, Australia
Krankenhaus d.Elisabethinen
Linz, Austria
Landeskrankenhaus Salzburg
Salzburg, Austria
AT-Vienna-HANUSCH
Vienna, Austria
...and 198 more locations