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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

ClinicalTrials.gov processed this record on August 01, 2014