Multiple Myeloma Clinical Trial
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
| NCT number | NCT00702247 |
| Other study ID # | 00019702/3174 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 2 |
| First received | June 19, 2008 |
| Last updated | June 19, 2008 |
| Start date | July 1999 |
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
| Status | Recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Università di Torino - Azienda Ospedaliera S.Giovanni Battista | Torino |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Ospedaliera San Giovanni Battista |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall survival | yearly | Yes | |
| Secondary | event free survival | yearly | Yes |
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