Multiple Myeloma Clinical Trial
Official title:
Phase II Study of Bortezomib, Melphalan, Prednisone (VMP) Followed by Lenalidomide Maintenance vs. VMP Without Maintenance in Myeloma Patients Not Eligible to High-dose Chemotherapy and Autologous Stem Cell Transplantation
This is a multicenter, randomized, blinded, 2-arm phase IIb trial that will compare the
efficacy and safety of Lenalidomide maintenance after Bortezomib/Melphalan/Prednison (VMP)
induction to VMP without maintenance (Placebo). In addition the trial will assess the
treatment of Revlimid/low dose Dexamethasone (Rd) as Salvage after VMP without sufficient
response (less than PR) in an observational arm. Key eligibility criteria include patients
with newly diagnosed multiple myeloma and who are 65 years of age or older or are not
candidates for high-dose chemotherapy and autologous stem cell transplantation. Patients with
poor performance status or serious coexistent medical conditions will be excluded from this
study. After registration all patients receive 6 cycles VMP (modified according to Mateos et
al.). Patients who receive at least a PR and completed VMP can be randomized to either
Lenalidomide 10 mg/d continuously maintenance or to placebo. Randomization will be stratified
according to the quality of response after VMP induction (PR vs. VGPR + stringent complete
remission [sCR] + CR). Patients that are not able to complete VMP due to toxicity but reached
at least a PR after a minimum of four cycles of therapy should immediately proceed to
randomization. Blinded phase continues until progression or end of study. After unblinding,
patients who received placebo should be treated with Rd.
Patients that do not reach PR after induction with VMP or are progressive during treatment
with VMP should not be randomized, but switched to the observation arm and treated with Rd
immediately. The study treatment ends with the confirmed progression on maintenance treatment
(Lenalidomide or placebo) for patients that reached PR with induction treatment, or with the
confirmed progression on second-line therapy with Revlimid® and Dexamethasone for patients
that did not reach PR on induction treatment. All patients will be followed up every 3 months
after end of study treatment, until end of study. The study ends two years after Last Patient
In (i.e. randomization for maintenance) if sufficient events for the primary endpoint were
received, but not later than 8 years after trial initiation (whatever comes first).
Primary objective
- Estimate the gain in progression-free survival (PFS) by maintenance with Lenalidomide after
induction with VMP in elderly patients or patients unfit for highdose chemotherapy in
comparison with placebo after VMP
Secondary study objectives
- To compare response rates of VMP and Lenalidomide maintenance versus VMP and placebo
- To compare overall survival probabilities between patients treated with Lenalidomide
maintenance and patients without maintenance treatment
- To compare the safety of VMP and Lenalidomide maintenance versus VMP and placebo
- To compare the QoL of VMP and Lenalidomide maintenance versus VMP and placebo
- To assess the safety and efficacy of Rd for poor responders on VMP
;
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