NCT01019174

Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined With Single Cyclophosphamide Doses IV in Patients With Relapsed/Refractory Multiple Myeloma

An Open, Randomized Clinical Phase I/II Trial to Investigate Maximum Tolerated Dose, Efficacy, and Safety of Lenalidomide/Low-dose Dexamethasone in Combination With Continuous Oral Cyclophosphamide Compared to Lenalidomide/Low-dose Dexamethasone Combined With Single Cyclophosphamide Doses IV in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and tolerability of LEN/low-dose DEX and continuous low-dose CY administered orally compared to LEN in combination with low-dose DEX and single CY doses IV in patients with relapsed MM.

Detailed description

This is an open, randomized, multicenter, phase I/II study with a parallel group design investigating an intravenous and an oral CY dosing schedule in combination with LEN and low-dose DEX in patients with refractory or relapsed MM. In phase I MTD of CY will be determined using a common dose escalation scheme with 3 to 6 patients per dose level. In phase II, efficacy and safety of the treatment regimens at the MTD will be investigated in 20 patients.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	comparison of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses intravenous
DRUG	Cyclophosphamide	comparison of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses intravenous

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2009-11-25
• Last updated: 2017-02-20

Locations

4 sites across 1 country: Germany