Continuous Lenalidomide Therapy Versus Observation Following Induction Without Lenalidomide, Pomalidomide or Thalidomide in Myeloma
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|ClinicalTrials.gov Identifier: NCT02155634|
Recruitment Status : Withdrawn (The study was terminated due to poor feasibility and lack of interest at the participating sites.)
First Posted : June 4, 2014
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Neoplasms Plasma Cells Paraproteinemias Blood Protein Disorders Hematologic Diseases Therapeutic Uses||Drug: Lenalidomide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3b, Randomized Trial of Continuous Revlimid® (Lenalidomide) Therapy Versus Observation Following Induction Therapy That Does Not Include Revlimid, Pomalyst® or Thalomid® in Newly Diagnosed Multiple Myeloma|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||March 2021|
Lenalidomide maintenance given until disease progression. Long term follow-up 5 years post last patient randomized.
Treatment with lenalidomide capsules 10 mg, 5mg daily or 5mg every other day given on days 1-21 of each 28 day cycle.
Other Name: Revlimid
No Intervention: Observation
Observation until disease progression. Long term follow-up 5 years post last patient randomized.
- Progression free survival (PFS) [ Time Frame: Approximately 36 months. ]Time from randomization to the documentation of disease progression
- Response Rate [ Time Frame: Approximately 36 months ]Response is defined according to the international Myeloma Working Group (IMWG) Response Criteria (Durie, 2006). Overall response rate over time (complete response [CR], very good partial response [VGPR], partial response [PR], stable disease [SD]
- Time to progression (TTP) [ Time Frame: Approximately 36 months ]The time to progression is defined from randomization to progression as defined by the international Myeloma Working Group (IMWG) Criteria (Durie, 2006)
- Overall survival (OS) [ Time Frame: Approximate 6.5 years ]Time from randomization to the date of death due to any cause
- Safety [ Time Frame: Approximate 6.5 years ]Number of patients with adverse events and relationship of adverse events, laboratory abnormalities, and hospitalizations to study drug / study observation
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): NCT02155634
|Study Director:||Yasir Nagarwala, MD||Celgene|