NCT01090089

Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m² augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before transplantation and lenalidomide maintenance after transplantation.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide, Dexamethasone	Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)
DRUG	Lenalidomide, Dexamethasone, PBSCT	Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years

Timeline

• Start date: 2010-03-01
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2010-03-19
• Last updated: 2023-02-23

Locations

31 sites across 1 country: Germany