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The Optimal Timing of a Second Autologous Peripheral Blood Stem Cell Transplantation in Patients (<61 Years) With Multiple Myeloma

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00207805
Enrollment
202
Registered
2005-09-21
Start date
2003-05-31
Completion date
Unknown
Last updated
2009-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

Autologous peripheral blood stem cell (PBSC) transplantation is now considered standard therapy in patients (\< 65 ans) with multiple myeloma. The Intergroupe Francophone du Myelome conducted a randomised trial of the treatment of multiple myeloma with high dose chemotherapy followed by either one or two successive autologous stem cell transplantation. The probabilities of event-free-survival and overall survival were doubled with a double transplant. The benefits were greatest among patients who had not had a very good partial response to the first transplant. The aim of this multicenter randomised trial in previously untreated patients with multiple myelome (stage II, III DS)is to assess the optimal timing of a second autologous stem-cell transplant.After a first-line therapy with thalidomide-dexamethasone followed by a PBSC collection, patients are randomly assigned to receive two autologous PBSC transplants (arm A)or one autologous PBSC transplant followed by a consolidation therapy with thalidomide-dexamethasone (arm B). Patients included in the arm B will receive a second transplant in case of disease progression on consolidation therapy, or in case of relapse in responders.

Interventions

optimal timining of a second autologous transplant

Sponsors

Centre National de Greffe de Moelle Osseuse
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 61 Years
Healthy volunteers
No

Inclusion criteria

* patients less than 61 years of age * Durie Salmon stage II or III * written and informed consent

Exclusion criteria

* Prior treatment for myeloma * ECOG performance score of 4 * Positive HIV test * Chronic respiratory disease (DLco \< 60%) * Systolic ejection fraction \< 50% * Pregnant or nursing women

Design outcomes

Primary

MeasureTime frame
Overall survival (from randomistion) of the 2 groups at 5 years

Secondary

MeasureTime frame
Event-free-survival

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026