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Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Hematopoietic Stem Cell Transplantation
Sponsored by
Azienda Ospedaliera San Giovanni Battista
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma, Newly diagnosed multiple myeloma, Tandem Auto-Allo Transplant, Overall survival, Event free survival, Disease response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Università di Torino - Azienda Ospedaliera S.Giovanni BattistaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

event free survival

Full Information

First Posted
June 19, 2008
Last Updated
June 19, 2008
Sponsor
Azienda Ospedaliera San Giovanni Battista
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1. Study Identification

Unique Protocol Identification Number
NCT00702247
Brief Title
Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliera San Giovanni Battista

4. Oversight

5. Study Description

Brief Summary
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma, Newly diagnosed multiple myeloma, Tandem Auto-Allo Transplant, Overall survival, Event free survival, Disease response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic Stem Cell Transplantation
Primary Outcome Measure Information:
Title
overall survival
Time Frame
yearly
Secondary Outcome Measure Information:
Title
event free survival
Time Frame
yearly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benedetto Bruno, MD, PhD
Phone
+39-011-6334419
Email
benedetto.bruno@unito.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Benedetto, MD, PhD
Organizational Affiliation
University of Torino - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università di Torino - Azienda Ospedaliera S.Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedetto Bruno, MD, PhD
Phone
+39-011-6334419
Email
benedetto.bruno@unito.it
First Name & Middle Initial & Last Name & Degree
Mario Boccadoro
Phone
+39-011-6336728
Email
mario.boccadoro@unito.it
First Name & Middle Initial & Last Name & Degree
Benedetto Bruno, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19064724
Citation
Bruno B, Rotta M, Patriarca F, Mattei D, Allione B, Carnevale-Schianca F, Sorasio R, Rambaldi A, Casini M, Parma M, Bavaro P, Onida F, Busca A, Castagna L, Benedetti E, Iori AP, Giaccone L, Palumbo A, Corradini P, Fanin R, Maloney D, Storb R, Baldi I, Ricardi U, Boccadoro M. Nonmyeloablative allografting for newly diagnosed multiple myeloma: the experience of the Gruppo Italiano Trapianti di Midollo. Blood. 2009 Apr 2;113(14):3375-82. doi: 10.1182/blood-2008-07-167379. Epub 2008 Dec 8.
Results Reference
derived

Learn more about this trial

Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)

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