drugset / Trial / NCT00915408
A Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and to evaluate the safety of cyclophosphamide when given on days 1 and 8 in a 28 day cycle in doses starting at 300mg ranging to 700mg in combination with Lenalidomide (Revlimid®) plus dexamethasone in patients who present with relapsed or refractory myeloma.
Timeline
- Start
- 2006-09
- Primary completion
- 2014-03
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 300 mg | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 400 mg | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 600 mg | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 700 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |