drugset / Trial / NCT01054196
Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study
Phase 1/2
Active not recruiting
52 enrolled
Weill Medical College of Cornell University
Celgene Corporation · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely added to high-dose melphalan prior to autologous stem cell transplantation (ASCT). B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by maintenance standard-dose lenalidomide improves the response rate and duration of response for relapsed multiple myeloma (RMM).
Timeline
- Start
- 2010-08
- Primary completion
- 2021-10
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 50 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 75 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 100 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 150 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 200 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 350 mg | Oral |
| Subject | Melphalan | Small molecule | 100 mg/m2 | Intravenous |