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

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Cyclophosphamide

• Registration Number: NCT01019174
• Lead Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Brief 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-07
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral application	Cyclophosphamide	oral application Cyclophosphamide
intravenous application	Cyclophosphamide	intravenous application Cyclophosphamide

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD) of CY (PO and IV) in combination with LEN/low-dose DEX	3 years
To investigate the best objective response (EBMT criteria) to both treatment regimens	3 years

Secondary Outcome Measures

Name	Time	Method
To investigate safety and tolerability of both treatment regimens	3 years
To investigate other efficacy parameters of both treatment regimens	3 years

Trial Locations

Locations (4)

University Clinic Ulm, Department Internal Medicine; 🇩🇪 Ulm, Germany

University Clinic München-Großhadern; 🇩🇪 München, Germany

Tübingen University, Department of Hematology/Oncology/Immunology; 🇩🇪 Tübingen, Germany

University of Münster, Department of Hematology/Oncology; 🇩🇪 Münster, Germany