Hematopoietic Stem Cell Transplantation in Myeloma

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Keywords

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hematopoietic Stem Cell Transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Benedetto Bruno, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy

Mario Boccadoro, MD

Role: STUDY_DIRECTOR

Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy

Locations

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Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista

Torino, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED

PMID: 17360989 (View on PubMed)

Other Identifiers

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572

Identifier Type: -

Identifier Source: org_study_id