Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedJune 20, 2008
June 1, 2008
June 19, 2008
June 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
yearly
Secondary Outcomes (1)
event free survival
yearly
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Università di Torino - Azienda Ospedaliera S.Giovanni Battista
Torino, 10126, Italy
Related Publications (1)
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.
PMID: 19064724DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Benedetto, MD, PhD
University of Torino - Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 20, 2008
Study Start
July 1, 1999
Last Updated
June 20, 2008
Record last verified: 2008-06