Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM (ARUMM)
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|ClinicalTrials.gov Identifier: NCT02112175|
Recruitment Status : Active, not recruiting
First Posted : April 11, 2014
Last Update Posted : December 4, 2018
The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma.
After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Lenalidomide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3B, Randomized Trail of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade (Bortezomib) Induction Therapy In Newly Diagnosed Multiple Myeloma|
|Actual Study Start Date :||April 30, 2014|
|Estimated Primary Completion Date :||October 12, 2020|
|Estimated Study Completion Date :||October 12, 2020|
Treatment Arm A: lenalidomide 10 mg/day orally from Days 1 to 21; given in 28-day cycles for up to disease progression.
- Overall Survival (OS) [ Time Frame: Approximately 6 years ]Is defined as the time from the date of randomization to the date of death due to any cause.
- Safety; Adverse Events (AE) [type, frequency, and severity of AEs, and relationship of AEs to investigational product (IP) SAEs, laboratory abnormalities, hospitalizations, and SPMs [ Time Frame: Approximately 6 years ]An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112175
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|Study Director:||Amine Bensmaine, MD||Celgene Corporation|