Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients

NCT00950768 | Completed Phase 3

• 1 other identifier: GISMM2001
• Study Type: interventional
• Target: 298
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study will be randomised before induction treatment either to receive two courses of melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e Salmon stage IIA-IIIB measurable multiple myeloma; age \< 65 years. Exclusion criteria included: prior treatment for myeloma; abnormal cardiac function, defined as systolic ejection fraction \<50%; abnormal pulmonary spirometry test; serum bilirubins \> 2.5 times normal and ALAT and/or ASAT \> 2 times normal; seropositivity for HIV, HCV or HBV, active non-hematologic malignancies. Induction therapy, PBSC mobilization, and autografting Initial treatment plan included induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2 on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan, 100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5 ug/kg, from days +3 until neutrophil count \> 1000/ul were achieved. Supportive care and toxicity grading Following autografting, all patients received standard prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0) were used for grading hematological and non-hematological toxicity.

Conditions

Multiple Myeloma; Diagnosis

Keywords

Myeloma; Melphalan; Autologous transplantation

Outcome Measures

Primary Outcomes (1)

• Primary endpoints of the study were Overall Survival defined as the time from diagnosis until death from any cause; Progression Free Survival defined as the time from diagnosis until death from any cause or date of first relapse or progression.

Secondary Outcomes (1)

• Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.

Study Arms (2)

Mel100

ACTIVE COMPARATOR

Procedure: Autologous transplantation

Mel200

EXPERIMENTAL

Procedure: Autologous transplantation

Interventions

Autologous transplantation PROCEDURE

Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2

Mel100; Mel200

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of untreated Durie \& Salmon stage IIA-IIIB measurable multiple myeloma;
• age \< 65 years.

You may not qualify if:

• prior treatment for myeloma;
• abnormal cardiac function, defined as systolic ejection fraction \<50%;
• abnormal pulmonary spirometry test;
• serum bilirubins \> 2.5 times normal and ALAT and/or ASAT \> 2 times normal;
• seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.

Sponsors & Collaborators

• Azienda Ospedaliera San Giovanni Battista: lead

Related Publications (1)

• Palumbo A, Bringhen S, Bruno B, Falcone AP, Liberati AM, Grasso M, Ria R, Pisani F, Cangialosi C, Caravita T, Levi A, Meloni G, Nozza A, Pregno P, Gabbas A, Callea V, Rizzo M, Annino L, De Stefano V, Musto P, Baldi I, Cavallo F, Petrucci MT, Massaia M, Boccadoro M. Melphalan 200 mg/m(2) versus melphalan 100 mg/m(2) in newly diagnosed myeloma patients: a prospective, multicenter phase 3 study. Blood. 2010 Mar 11;115(10):1873-9. doi: 10.1182/blood-2009-09-241737. Epub 2009 Dec 1.

  PMID: 19965659 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Disease; Neoplasms, Plasma Cell

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Mario Boccadoro, MD

  Division of Hematology - University of Torino - A.O.U. San Giovanni Battista

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 3, 2009
• Study Start: February 1, 2002
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 3, 2009

Record last verified: 2009-07