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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. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was:  Recruiting
Information provided by:
Azienda Ospedaliera San Giovanni Battista Identifier:
First received: June 19, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
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 ]

Secondary Outcome Measures:
  • event free survival [ Time Frame: yearly ]

Study Start Date: July 1999
Arms Assigned Interventions
Experimental: 1 Procedure: Hematopoietic Stem Cell Transplantation


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00702247

Contact: Benedetto Bruno, MD, PhD +39-011-6334419

Università di Torino - Azienda Ospedaliera S.Giovanni Battista Recruiting
Torino, Italy, 10126
Contact: Benedetto Bruno, MD, PhD    +39-011-6334419   
Contact: Mario Boccadoro    +39-011-6336728   
Principal Investigator: Benedetto Bruno, MD, PhD         
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Principal Investigator: Bruno Benedetto, MD, PhD University of Torino - Italy
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00702247     History of Changes
Other Study ID Numbers: 00019702/3174
Study First Received: June 19, 2008
Last Updated: June 19, 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
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases processed this record on August 21, 2017