Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma
A Controlled, Parallel-Group, Randomized, Open-Label Study to Evaluate Two Lenalidomide Dose Regimens When Used in Combination With Low Dose Dexamethasone for the Treatment of Subjects With Relapsed Multiple Myeloma
Sponsor: Boston VA Research Institute, Inc.
A PHASE2 clinical study on Multiple Myeloma, this trial is completed. The trial is conducted by Boston VA Research Institute, Inc. and has accumulated 11 data snapshots since 2010. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Primary Objective:
• Evaluate the frequency of dose reductions in two different lenalidomide dose regimens.
Secondary Objectives:
* Evaluate the efficacy of two different lenalidomide dose regimens in patients with multiple myeloma using the EBMT and IMWG criteria.
* Evaluate the duration of response of 15 mg Lenalidomide and 25 mg of Lenalidomide when used in combination with Low Dose Dexamethasone.
* Evaluate the safety of 15 mg and 25 mg of Lenalidomide regiments when in combination with dexamethasone.
* Explore blood and cellular levels of angiogenic factors, cytokines, and adhesion molecules.
Primary Objective:
• Evaluate the frequency of dose reductions in two different lenalidomide dose regimens.
Secondary Objectives:
* Evaluate the efficacy of two different lenalidomide dose regimens in patients with multiple myeloma using the EBMT and IMWG criteria. * Evaluate the duration of response of 15 mg Lenalidomide and 25 mg of Lenalidomide when used in combination with Low Dose Dexamethasone. * Evaluate the safety of 15 mg and 25 mg of Lenalidomide regiments when in combination with dexamethasone. * Explore blood and cellular levels of angiogenic factors, cytokines, and adhesion molecules.
Status Flow
Change History
11 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE2
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE2
-
Nov 2021 — Dec 2022 [monthly]
Completed PHASE2
▶ Show 6 earlier versions
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Feb 2021 — Nov 2021 [monthly]
Completed PHASE2
Status: Unknown Status → Completed
-
Jan 2021 — Feb 2021 [monthly]
Unknown Status PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE2
-
Mar 2018 — Jun 2018 [monthly]
Unknown Status PHASE2
Status: Active Not Recruiting → Unknown Status
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Feb 2017 — Mar 2018 [monthly]
Active Not Recruiting PHASE2
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE2
First recorded
Aug 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Boston VA Research Institute, Inc.
- Celgene Corporation
- Edward Hines Jr. VA Hospital
- Kansas City Veteran Affairs Medical Center
- Michael E. DeBakey VA Medical Center
- VA Greater Los Angeles Healthcare System
- VA Pittsburgh Healthcare System
For direct contact, visit the study record on ClinicalTrials.gov .