Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
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ClinicalTrials.gov Identifier: NCT00702247 |
Recruitment Status
: Unknown
Verified June 2008 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was: Recruiting
First Posted
: June 20, 2008
Last Update Posted
: June 20, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Procedure: Hematopoietic Stem Cell Transplantation | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 |
Study Start Date : | July 1999 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 | Procedure: Hematopoietic Stem Cell Transplantation |
- overall survival [ Time Frame: yearly ]
- event free survival [ Time Frame: yearly ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702247
Contact: Benedetto Bruno, MD, PhD | +39-011-6334419 | benedetto.bruno@unito.it |
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 |
Principal Investigator: | Bruno Benedetto, MD, PhD | University of Torino - Italy |
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 |
First Posted: | June 20, 2008 Key Record Dates |
Last Update Posted: | June 20, 2008 |
Last Verified: | June 2008 |
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 Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |