Phase III-study for Evaluation of Induction Therapy Before Stem Cell Mobilization and Tandem High-dose Melphalan in Multiple Myeloma Patients 60 to 70 Years of Age (DSMM-II)

NCT02288741 Phase 3 COMPLETED

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.

Details

Lead sponsor	WiSP Wissenschaftlicher Service Pharma GmbH
Phase	Phase 3
Status	COMPLETED
Enrolment	549
Start date	2001-08
Completion	2012-09

Conditions

• Multiple Myeloma

Interventions

• Anthracycline/dexamethasone-based induction chemotherapy
• Dexamethasone for control of symptoms
• Tumor-reduction chemotherapy and stem cell mobilization
• Stem cell apheresis
• Tandem high-dose chemotherapy (melphalan)
• Autologous peripheral blood stem cell transplantation

Primary outcomes

• Event free survival — From randomization to 10 years follow up
  Calculated according to the method of Kaplan and Meier