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

This study is currently recruiting participants.

Verified by Azienda Ospedaliera San Giovanni Battista, June 2008

First Received: June 19, 2008 No Changes Posted

Sponsored by:	Azienda Ospedaliera San Giovanni Battista
Information provided by:	Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:	NCT00702247

Purpose

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

Condition	Intervention	Phase
Multiple Myeloma	Procedure: Hematopoietic Stem Cell Transplantation	Phase II

Study Type:	Interventional
Study Design:	Treatment, Single Group Assignment
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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:

overall survival [ Time Frame: yearly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

event free survival [ Time Frame: yearly ] [ Designated as safety issue: Yes ]

Study Start Date:

July 1999

Arms	Assigned Interventions
1: Experimental	Procedure: Hematopoietic Stem Cell Transplantation

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702247

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

No publications provided by Azienda Ospedaliera San Giovanni Battista

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Dec 8.

Study ID Numbers:	00019702/3174
Study First Received:	June 19, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00702247 History of Changes
Health Authority:	Italy: Ministry of Health

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

Study placed in the following topic categories:

Melphalan
Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 09, 2009