VELCADE-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) Incorporated Into Double Autotransplantation for Untreated Multiple Myeloma (MM)

Summary

Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as induction therapy in preparation for, and as consolidation after, melphalan-based double autologous stem cell transplantation for previously untreated patients aged ≤65 years with symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of CR plus nCR to double transplantation and subsequent consolidation therapy, time to progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile of both VTD and TD.

Conditions

• Multiple Myeloma

Interventions

DRUG

Velcade

* INDUCTION THERAPY: 1.3 mg/sqm as a bolus i.v. injection on days 1, 4, 8 and 11 (3 courses, 21 days each) * REMISSION CONSOLIDATION THERAPY: 1.3 mg/sqm as a bolus i.v. injection on days 1, 8, 15 and 22 (2 courses, 35 days each)

DRUG

Thalidomide

* INDUCTION THERAPY: 100 mg/d on days 1-14, 200 mg/d on days 15-63 (in case of delay of HD-CTX , Thalidomide will be continued until the day before Cyclophosphamide as priming therapy for PBSC collection) * AFTER PBSC COLLECTION: 100 mg/d from day after last PBSC collection until the day before first course of MEL-200 * AFTER FIRST TRANSPLANTATION: 100 mg/d from recovery of hematopoiesis until the day before the second course of MEL-200 * REMISSION CONSOLIDATION THERAPY (starting 3 months after the second autologous transplantation): 100 mg/d days 1-70

DRUG

Dexamethasone

* INDUCTION THERAPY 1. VTD ARM: 40 mg/d days 1-2, 4-5, 8-9 and 11-12 (3 cycles, 21 days each) 2. TD ARM: 40 mg/d days 1-4 and 9-12 (3 cycles, 21 days each) * AFTER PBSC COLLECTION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide) * AFTER FIRST TRANSPLANTATION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide) and repeated every 28 days, for 3 months * REMISSION CONSOLIDATION THERAPY (starting 3 months after the second autologous transplantation) 1. VTD ARM: 40 mg/d days 1-2, 8-9, 15-16 and 22-23 (2 cycles, 35 days each) 2. TD ARM: 40 mg/d days 14 and 20-23 (2 cycles, 35 days each)

PROCEDURE

Peripheral Blood Stem Cell (PBSC) collection

* Cyclophosphamide (CTX): 4 g/sqm given in a single day (day 0) * G-CSF: 10 µcg/kg/d, starting on day +2 from CTX and continuing until completion of PBSC collection

PROCEDURE

First Autologous Transplantation

* HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0) * G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10\^9/L for 3 consecutive days

PROCEDURE

Second Autologous Transplantation

* HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0) * G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10\^9/L for 3 consecutive days

Sponsors & Collaborators

• Janssen-Cilag S.p.A.

  collaborator INDUSTRY

• Michele Cavo

  lead OTHER

Principal Investigators

• Michele Cavo, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2008-08-31

Completion

2015-12-31

Countries

• Italy

Study Locations