drugset / Trial / NCT02288741

Tandem Melphalan and Autolog. SCT in MM Patients 60 to 70 Years of Age With and Without Induction Chemotherapy

NCT02288741

Phase 3 Completed 549 enrolled WiSP Wissenschaftlicher Service Pharma GmbH
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1) or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was scheduled for all patients.

Timeline

Start
2001-08
Primary completion
2012-09
Completion
2012-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified
Comparator Dexamethasone Small molecule 40 mg Oral
Subject Doxorubicin Other / unclassified
Subject Idarubicin Small molecule
Subject Vincristine Small molecule
Background Epirubicin Small molecule 75 mg/m2 Intravenous
Background Etoposide Small molecule 120 mg/m2 Intravenous
Background Ifosfamide Small molecule 1900 mg/m2 Intravenous
Background Melphalan Small molecule 70 mg/m2

Indications