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Status unknownNCT00415987Updated Jun 20, 2008

Hematopoietic Stem Cell Transplantation in Myeloma

A Phase 2/3 interventional study of Hematopoietic Stem Cell Transplantation in Multiple Myeloma, sponsored by Azienda Ospedaliera San Giovanni Battista. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-06-20.

Sponsored by Azienda Ospedaliera San Giovanni Battista · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The treatment assignment is based on the presence or absence of an HLA-identical sibling donor (Genetic Randomisation, NOT formal Randomisation). Patients with suitable HLA-identical sibling donors are offered a tandem transplant approach consisting of standard autografting nonmyeloablative radiotherapy and allografting. Patients without HLA-identical siblings are treated with standard double autologous transplantation as per Institutional guidelines or enrolled in other treatment programs approved by local IRBs.This is a multi-center study. The Division of Hematology of University of Torino at the S.G.B. Hospital, Torino, Italy, is the co-ordinating Center.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

Browse Multiple Myeloma studies →

Lead sponsor

Azienda Ospedaliera San Giovanni Battista is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • ProcedureHematopoietic Stem Cell Transplantation
06

What researchers measure

Primary outcomes

  1. Survival Outcomes

Secondary outcomes

  1. Response Rate

  2. Toxicity

07

Study locations

1 site
  • Ematologia Universitaria Azienda Ospedaliera San Giovanni Battista
    Torino, 10126, Italy
08

References and documents

Publications

  • Bruno B, Rotta M, Patriarca F, Mordini N, Allione B, Carnevale-Schianca F, Giaccone L, Sorasio R, Omede P, Baldi I, Bringhen S, Massaia M, Aglietta M, Levis A, Gallamini A, Fanin R, Palumbo A, Storb R, Ciccone G, Boccadoro M. A comparison of allografting with autografting for newly diagnosed myeloma. N Engl J Med. 2007 Mar 15;356(11):1110-20. doi: 10.1056/NEJMoa065464. PubMed 17360989 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00415987
Lead sponsor
Azienda Ospedaliera San Giovanni Battista
First posted
Dec 27, 2006
Completion
Sep 2006
Last update
Jun 20, 2008

Study contacts

Benedetto Bruno, MD, PhD
principal investigator · Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy
Mario Boccadoro, MD
study director · Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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