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Phase 2/Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival Outcomes

Principal Investigator

Benedetto Bruno, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Divisione Ematologia, Università di Torino, Azienda Ospedaliera San Giovanni Battista, Torino, Italy

Authority:

Italy: Ethics Committee

Study ID:

572

NCT ID:

NCT00415987

Start Date:

Completion Date:

September 2006

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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