Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma, Newly diagnosed multiple myeloma, Tandem Auto-Allo Transplant, Overall survival, Event free survival, Disease response
Study Type
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Name: Hematopoietic Stem Cell Transplantation
Type: Procedure
Overall Status
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Università di Torino - Azienda Ospedaliera S.Giovanni Battista
Torino, Italy
Status: Recruiting
Contact: Benedetto Bruno, MD, PhD - +39-011-6334419 - benedetto.bruno@unito.it
Start Date
July 1999
Azienda Ospedaliera San Giovanni Battista
Azienda Ospedaliera San Giovanni Battista
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page