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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Azienda Ospedaliera San Giovanni Battista

ClinicalTrials.gov Identifier:

NCT00702247

First received: June 19, 2008

Last updated: NA

Last verified: June 2008

History: No changes posted

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 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Genetic and Rare Diseases Information Center resources: 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
Experimental: 1	Procedure: Hematopoietic Stem Cell Transplantation

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received:	June 19, 2008
Last Updated:	June 19, 2008
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

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

ClinicalTrials.gov processed this record on September 23, 2016

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