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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
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 :	July 1999

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. overall survival [ Time Frame: yearly ]

Secondary Outcome Measures :

1. event free survival [ Time Frame: yearly ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Contacts

Contact: Benedetto Bruno, MD, PhD	+39-011-6334419	benedetto.bruno@unito.it

Locations

Italy
Università di Torino - Azienda Ospedaliera S.Giovanni Battista	Recruiting
Torino, Italy, 10126
Contact: Benedetto Bruno, MD, PhD +39-011-6334419 benedetto.bruno@unito.it
Contact: Mario Boccadoro +39-011-6336728 mario.boccadoro@unito.it
Principal Investigator: Benedetto Bruno, MD, PhD

Sponsors and Collaborators

Azienda Ospedaliera San Giovanni Battista

Investigators

Principal Investigator:	Bruno Benedetto, MD, PhD	University of Torino - Italy

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bruno B, Rotta M, Patriarca F, Mattei D, Allione B, Carnevale-Schianca F, Sorasio R, Rambaldi A, Casini M, Parma M, Bavaro P, Onida F, Busca A, Castagna L, Benedetti E, Iori AP, Giaccone L, Palumbo A, Corradini P, Fanin R, Maloney D, Storb R, Baldi I, Ricardi U, Boccadoro M. Nonmyeloablative allografting for newly diagnosed multiple myeloma: the experience of the Gruppo Italiano Trapianti di Midollo. Blood. 2009 Apr 2;113(14):3375-82. doi: 10.1182/blood-2008-07-167379. Epub 2008 Dec 8.

ClinicalTrials.gov Identifier:	NCT00702247 History of Changes
Other Study ID Numbers:	00019702/3174
First Posted:	June 20, 2008
Last Update Posted:	June 20, 2008
Last Verified:	June 2008

Keywords provided by Azienda Ospedaliera San Giovanni Battista:

Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma; Newly diagnosed multiple myeloma; Tandem Auto-Allo Transplant	Overall survival; Event free survival; Disease response

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases	Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases