Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
NCT ID: NCT00702247
Last Updated: 2008-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
1999-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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1
Hematopoietic Stem Cell Transplantation
Interventions
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Hematopoietic Stem Cell Transplantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Azienda Ospedaliera San Giovanni Battista
OTHER
Principal Investigators
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Bruno Benedetto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Torino - Italy
Locations
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Università di Torino - Azienda Ospedaliera S.Giovanni Battista
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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Benedetto Bruno, MD, PhD
Role: primary
Mario Boccadoro
Role: backup
References
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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.
Other Identifiers
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00019702/3174
Identifier Type: -
Identifier Source: org_study_id