At a glance
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Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Lenalidomide, Prednisone, and 1 other intervention for Multiple Myeloma. Completed, enrolled 27 participants across 1 site.
Detailed Summary
The purpose of this research is to estimate the effectiveness of a response adapted approach with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed standard risk multiple myeloma. This means that participants will be given the study drug, lenalidomide but depending on how they respond to this drug they may also be given dexamethasone and/or prednisone to help with their treatment.
Study Details
Timeline
Interventions
* Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; * Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; * Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; * Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; * Dose Level -4: Discontinue
* Starting Dose: 100 mg PO days 1-5 every 28 days; * Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; * Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; * Dose level -3: Discontinue
* Starting Dose: 40 mg daily on days 1 - 4 every 28 days; * Dose level -1: 20 mg daily on days 1 - 4 every 28 days; * Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; * Dose level -2: 10 mg daily on days 1 - 4 every 28 days; * Dose level -3: Discontinue