Hematopoietic Stem Cell Transplantation in Myeloma

Azienda Ospedaliera San Giovanni Battista

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Multiple Myeloma

Interventions

Hematopoietic Stem Cell TransplantationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista

Torino, Italy

Outcomes

Primary Outcomes

Survival Outcomes

Secondary Outcomes

Response Rate

Toxicity

Data from ClinicalTrials.gov

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