Hematopoietic Stem Cell Transplantation in Myeloma
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The treatment assignment is based on the presence or absence of an HLA-identical sibling donor (Genetic Randomisation, NOT formal Randomisation). Patients with suitable HLA-identical sibling donors are offered a tandem transplant approach consisting of standard autografting nonmyeloablative radiotherapy and allografting. Patients without HLA-identical siblings are treated with standard double autologous transplantation as per Institutional guidelines or enrolled in other treatment programs approved by local IRBs.This is a multi-center study. The Division of Hematology of University of Torino at the S.G.B. Hospital, Torino, Italy, is the co-ordinating Center.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 26, 2006
CompletedFirst Posted
Study publicly available on registry
December 27, 2006
CompletedJune 20, 2008
June 1, 2008
December 26, 2006
June 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival Outcomes
Secondary Outcomes (2)
Response Rate
Toxicity
Interventions
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)
Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista
Torino, 10126, Italy
Related Publications (1)
Bruno B, Rotta M, Patriarca F, Mordini N, Allione B, Carnevale-Schianca F, Giaccone L, Sorasio R, Omede P, Baldi I, Bringhen S, Massaia M, Aglietta M, Levis A, Gallamini A, Fanin R, Palumbo A, Storb R, Ciccone G, Boccadoro M. A comparison of allografting with autografting for newly diagnosed myeloma. N Engl J Med. 2007 Mar 15;356(11):1110-20. doi: 10.1056/NEJMoa065464.
PMID: 17360989DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benedetto Bruno, MD, PhD
Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy
- STUDY DIRECTOR
Mario Boccadoro, MD
Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 26, 2006
First Posted
December 27, 2006
Study Completion
September 1, 2006
Last Updated
June 20, 2008
Record last verified: 2008-06