Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)

Azienda Ospedaliera San Giovanni Battista

Status and phase: Unknown; Phase 2

Conditions: Multiple Myeloma

Treatments: Procedure: Hematopoietic Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00702247

00019702/3174

Details and patient eligibility

About

To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

0 participants in 1 patient group

1

Experimental group

Treatment:

Procedure: Hematopoietic Stem Cell Transplantation