NCT02288741

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH · Academic / Other
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In arm A1, patients received 4 cycles of conventional induction therapy with anthracycline/dexamethasone-based regimens. Specified in the protocol were vincristine/doxorubicin/dexamethasone (VAD), idarubicin/dexamethasone (ID) and cyclophosphamide/doxorubicin/dexamethasone (CAD). In arm A2, patients were planned to receive only dexamethasone 40 mg orally on days 1-4 and 8-11 for symptom control before stem cell mobilization. For the patients in arm B, a maximum of 6 cycles of induction chemotherapy was allowed. Following this, the treatment was identical for all patients. For stem cell mobilization, an age-adjusted IEV-regimen with granulocyte-colony stimulating factor (G-CSF) was recommended. The target dose for stem cell collection was 6 x 10E+6 CD34 (cluster of differentiation 34)-positive cells/kg (2 transplants and one back-up). The standard dose for each transplantation was 2 x 10E+6 CD34-positive cells/kg. High-dose melphalan at a total dose of 140 mg/m² (MEL140) was given in two doses of 70 mg/m² on days -3 and -2. Stem cell transplantation (SCT) was performed on day 0. A second MEL140 course was planned two months after the first. Regular bisphosphonate treatment was recommended.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Anthracycline/dexamethasone-based induction chemotherapy	4 cycles of anthracycline/dexamethasone-based chemotherapy
DRUG	Dexamethasone for control of symptoms	2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)
DRUG	Tumor-reduction chemotherapy and stem cell mobilization	Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc)
PROCEDURE	Stem cell apheresis	stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg
DRUG	Tandem high-dose chemotherapy (melphalan)	Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)
PROCEDURE	Autologous peripheral blood stem cell transplantation	Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

Timeline

• Start date: 2001-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2014-11-11
• Last updated: 2014-11-11