Clinical trial NCT00702247: Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
Official title: Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
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
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
First posted: 2008-06-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: overall survival
timeFrame: yearly
Secondary outcomes:
measure: event free survival
timeFrame: yearly
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Università di Torino - Azienda Ospedaliera S.Giovanni Battista
Study officials:
affiliation: University of Torino - Italy
name: Bruno Benedetto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruno B, Rotta M, Patriarca F, Mattei D, Allione B, Carnevale-Schianca F, Sorasio R, Rambaldi A, Casini M, Parma M, Bavaro P, Onida F, Busca A, Castagna L, Benedetti E, Iori AP, Giaccone L, Palumbo A, Corradini P, Fanin R, Maloney D, Storb R, Baldi I, Ricardi U, Boccadoro M. Nonmyeloablative allografting for newly diagnosed multiple myeloma: the experience of the Gruppo Italiano Trapianti di Midollo. Blood. 2009 Apr 2;113(14):3375-82. doi: 10.1182/blood-2008-07-167379. Epub 2008 Dec 8.