Hematopoietic Stem Cell Transplantation in Myeloma

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00415987
• Other study ID #: 572
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: December 26, 2006
• Last updated: June 19, 2008
• Est. completion date: September 2006

Study information

• Verified date: June 2008
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• Hematopoietic Stem Cell Transplantation

Locations

Country	Name	City	State
Italy	Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Outcomes
Secondary	Response Rate
Secondary	Toxicity