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Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

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 December 2006 by Azienda Ospedaliera San Giovanni Battista.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327314
First Posted: May 18, 2006
Last Update Posted: December 28, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Azienda Ospedaliera San Giovanni Battista
  Purpose
The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.

Condition Intervention Phase
Multiple Myeloma Procedure: Transplantation Procedure: Hematopoietic cell transplantation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Estimated Enrollment: 100
Study Start Date: December 2002
Estimated Study Completion Date: October 2006
Detailed Description:

Primary end points are engraftment and non-relapse mortality. Secondary end points are disease response, overall survival, progression and event free survivals. Patient eligibility criteria.

Inclusion criteria included:

  • Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
  • Age > 18 and ≤ 65 years at the start of the donor search
  • Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
  • Capacity to give informed consent

Exclusion criteria included:

  • Age > 65 years
  • Karnofsky performance status score < 60%
  • Progressive disease or stable disease for less than three months
  • Central nervous system (CNS) involvement
  • Left ventricular ejection fraction < 35% or symptomatic heart failure
  • Poorly controlled hypertension
  • Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
  • Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
  • HIV positive patients
  • Pregnancy
  • Refusal to use contraceptive techniques during and for 12 months following treatment

Informed consent is obtained during study registration from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
  • Age > 18 and ≤ 65 years at the start of the donor search
  • Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
  • Capacity to give informed consent

Exclusion Criteria:

  • Age > 65 years
  • Karnofsky performance status score < 60%
  • Progressive disease or stable disease for less than three months
  • Central nervous system involvement
  • Left ventricular ejection fraction < 35% or symptomatic heart failure
  • Poorly controlled hypertension
  • Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
  • Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
  • HIV positive patients
  • Pregnancy
  • Refusal to use contraceptive techniques during and for 12 months following treatment
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00327314


Contacts
Contact: Benedetto Bruno, MD, PhD +39-011-6334419 benedetto.bruno@unito.it
Contact: Luisa Giaccone, MD +39-011-6334419 luisa.giaccone@unito.it

Locations
Italy
Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista Recruiting
Torino, Italy, 10126
Principal Investigator: Benedetto Bruno, MD, PhD         
Sub-Investigator: Luisa Giaccone, MD         
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Investigators
Principal Investigator: Benedetto Bruno, MD, PhD Divisione di Ematologia _ Azienda Ospedaliera S G Battista di Torino
  More Information

ClinicalTrials.gov Identifier: NCT00327314     History of Changes
Other Study ID Numbers: MM 1641
First Submitted: May 16, 2006
First Posted: May 18, 2006
Last Update Posted: December 28, 2006
Last Verified: December 2006

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