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Trial Title:
Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
NCT ID:
NCT00702247
Condition:
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:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Intervention:
Intervention type:
Procedure
Intervention name:
Hematopoietic Stem Cell Transplantation
Arm group label:
1
Summary:
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Università di Torino - Azienda Ospedaliera S.Giovanni Battista
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Benedetto Bruno, MD, PhD
Phone:
+39-011-6334419
Email:
benedetto.bruno@unito.it
Contact backup:
Last name:
Mario Boccadoro
Phone:
+39-011-6336728
Email:
mario.boccadoro@unito.it
Investigator:
Last name:
Benedetto Bruno, MD, PhD
Email:
Principal Investigator
Start date:
July 1999
Lead sponsor:
Agency:
Azienda Ospedaliera San Giovanni Battista
Agency class:
Other
Source:
Azienda Ospedaliera San Giovanni Battista
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00702247
