Know Cancer

or
forgot password

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


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

Thank you

Trial Information

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


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:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

yearly

Safety Issue:

Yes

Principal Investigator

Bruno Benedetto, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Torino - Italy

Authority:

Italy: Ministry of Health

Study ID:

00019702/3174

NCT ID:

NCT00702247

Start Date:

July 1999

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma
  • Newly diagnosed multiple myeloma
  • Tandem Auto-Allo Transplant
  • Overall survival
  • Event free survival
  • Disease response
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location