Health Condition 1: null- Multiple Myeloma Health Condition 2: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Lenalidomide: 25 mg PO daily for 21 days q 28days for total duration of 4 months
Intervention2: Lenalidomide: 25 mg daily for 21 days
Control Intervention1: Thalidomide: 100 mg PO daily
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a) Age 18 to 70 years b) Adequate hemogram, liver, heart and kidney function c) Performance status 0 to 2 (ECOG) d) Two negative pregnancy tests (one before and the second 4 weeks after starting Thalidomide or Lenalidomide) e) Willingness to participate in the study
Exclusion criteria
Exclusion criteria: Hypersensitivity reaction to Thalidomide or Lenalidomide in the past b) Pre-existing peripheral neuropathy more than grade 2 c) Uncontrolled diabetes mellitus d) Renal failure e) Significant ischemic cardiac disease eg LBBB f) Uncontrolled psychiatric (depressive) disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare progression-free survival between patients on Thalidomide and Lenalidomide maintenance Timepoint: At the end of 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the acute and cumulative toxicity of the Thalidomide and Lenalidomide 2. To compare the effect of maintenance therapy on the patient?s Quality of Life 3.To determine the rate of conversion from partial response (PR) or very good partial response (VGPR) to VGPR or complete response (CR) respectively 4. To identify those patients who are need and are likely to benefit from maintenance therapy Timepoint: At the end of 3 years | — |
Countries
India
Contacts
Public ContactLalit Kumar
Department of Medical Oncology
Outcome results
None listed