Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Azienda Ospedaliera San Giovanni Battista
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT00702247
First received: June 19, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
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Purpose
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Procedure: Hematopoietic Stem Cell Transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Azienda Ospedaliera San Giovanni Battista:
Primary Outcome Measures:
- overall survival [ Time Frame: yearly ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- event free survival [ Time Frame: yearly ] [ Designated as safety issue: Yes ]
| Study Start Date: | July 1999 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Procedure: Hematopoietic Stem Cell Transplantation |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00702247
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702247
Contacts
| Contact: Benedetto Bruno, MD, PhD | +39-011-6334419 | benedetto.bruno@unito.it |
Locations
| Italy | |
| Università di Torino - Azienda Ospedaliera S.Giovanni Battista | Recruiting |
| Torino, Italy, 10126 | |
| Contact: Benedetto Bruno, MD, PhD +39-011-6334419 benedetto.bruno@unito.it | |
| Contact: Mario Boccadoro +39-011-6336728 mario.boccadoro@unito.it | |
| Principal Investigator: Benedetto Bruno, MD, PhD | |
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Investigators
| Principal Investigator: | Bruno Benedetto, MD, PhD | University of Torino - Italy |
More Information
No publications provided by Azienda Ospedaliera San Giovanni Battista
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00702247 History of Changes |
| Other Study ID Numbers: | 00019702/3174 |
| Study First Received: | June 19, 2008 |
| Last Updated: | June 19, 2008 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Azienda Ospedaliera San Giovanni Battista:
|
Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma Newly diagnosed multiple myeloma Tandem Auto-Allo Transplant |
Overall survival Event free survival Disease response |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Hemostatic Disorders |
Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Paraproteinemias Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015