Hematopoietic Stem Cell Transplantation in Myeloma

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00415987

Enrollment

Unknown

Registered

2006-12-27

Start date

Unknown

Completion date

2006-09-30

Last updated

2008-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

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.

Interventions

PROCEDUREHematopoietic Stem Cell Transplantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Survival Outcomes	—

Secondary

Measure	Time frame
Response Rate	—
Toxicity	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026