A Study of Low Dose Lenalidomide and Dexamethasone in Relapsed/Refractory Myeloma in Patients at High Risk for Myelosuppression

Multiple Myeloma Clinical Trial

Official title: Phase II Trial of Low Dose Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (Rev-Lite) in Patients at High Risk for Myelosuppression

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to see whether combination of low dose lenalidomide(10mg)+ dexamethasone is equally effective in treating relapsed/refractory myeloma in the group of elderly patients and other patients at risk of myelosuppression, whilst producing less side effects, especially myelosuppression compared to the higher dose of lenalidomide of 25mg used in the MM-009 and MM-010 trials.

Clinical Trial Description

Lenalidomide has proven efficacy in myeloma. In the Phase I studies with lenalidomide monotherapy, responses were observed at doses of 5mg, 10mg and 25mg. The dose limiting toxicity of lenalidomide monotherapy was myelosuppression·

In the International MM-010 and MM-009 studies, lenalidomide was administered at 25mg d1-d21 (with pulse dexamethasone) of a 28 day cycle. Although the overall response rate and time to progression were impressive, a significant toxicity was myelosuppression. The average age in these 2 studies was approximately 63 years, some 7 years lower than the median age for myeloma. The median number of prior therapies was 2. Thus, if lenalidomide therapy is to be optimally applied in an older and/or more heavily pre-treated population, a simpler, less toxic regimen would be valuable. Low dose (15mg) lenalidomide (Rev-Lite) with dexamethasone may achieve this goal·

Based on analysis of the MM009 and MM010 data the patients at highest risk for myelosuppression and subsequent dose reduction were those over the age of 60 years (approx 30% risk which increased to approx 50% by 70 years).It is hypothesized that patients with lower base-line platelets may also be at higher risk of lenalidomide-induced myelosuppression. Little is known about lenalidomide tolerance in patients with impaired renal function, consequently patients with relatively poorer renal function will also be enrolled into this study. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT00482261
• Study type: Interventional
• Source: Peter MacCallum Cancer Centre, Australia
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2007
• Completion date: September 2013