Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)

Sponsor

Azienda Ospedaliera San Giovanni Battista (Other)

Overall Status

Unknown status

CT.gov ID

NCT00702247

Collaborator

(none)

Location

Arm

Study Details

Study Description

Brief Summary

To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Procedure: Hematopoietic Stem Cell Transplantation	Phase 2

Study Design

Study Type:

Interventional

Allocation:

N/A

Intervention Model:

Single Group Assignment

Primary Purpose:

Treatment

Official Title:

Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI

Study Start Date :

Jul 1, 1999

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Procedure: Hematopoietic Stem Cell Transplantation

Arm

Intervention/Treatment

Experimental: 1

Procedure: Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcome Measures

overall survival [yearly]

Secondary Outcome Measures

event free survival [yearly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Durie-Salmon stage IIA-IIIB multiple myeloma
Age > 18 and ≤ 65 years
Previously untreated myeloma
Presence of a sibling (potential donor)
Bilirubins < twice normal;ALAT and ASAT < four times normal
Left ventricular ejection fraction > 40%
Creatinine clearances > 40 mL/min
Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) > 40% and/or need for continuous oxygen supplementation
Karnofsky performance status > 60%
Patients must give written informed consent

Exclusion Criteria:

Age > 65 years
Previously treated myeloma
Absence of a sibling (genetic randomisation cannot be applied)
Karnofsky performance status score < 60%
HIV-infection
Pregnancy
Refusal to use contraceptive techniques during and for 12 months following treatment
Patients unable to give written informed consent
PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.