Multiple Myeloma Clinical Trial
Official title:
QUIREDEX: A National, Open-Label, Multicenter, Randomized, Phase III Study of Revlimid (Lenalidomide) and Dexamethasone (ReDex) Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression
The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM. The second one is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety and tolerability of the treatment
A total of up to 120 patients diagnosed of smoldering Multiple Myeloma with high risk of
progression to symptomatic MM will be included.
Patients will be stratified according its diagnosis date and randomized 1 to 1 to receive
Revlimid and Dexamethasone (Group A) in 9 treatment cycles and maintenance with lower doses
until progression or No treatment and observation until progression (Group B).
The patients will be evaluated at scheduled visits in up to three study periods:
Pre-treatment, Treatment and Follow up.
The Pre-treatment includes Screening and baseline visits. After providing informed consent,
patients will be evaluated for study eligibility and then Patients will be stratified and
randomized (1:1) to Group A or Group B.
During Treatment Period patients will be evaluated once a month. Once the treatment period
has finished a maintenance treatment with low doses of Revlimid and Dexamethasone will be
carry out in Group A. During this period we will evaluate response, progression-free
survival and global survival every two months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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