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Allogeneic Stem Cell Transplantation From Unrelated Donors After Dose-Reduced Intensity Conditioning Regimen for Patients With Multiple Myeloma and Relapse After Autologous Stem Cell Transplantation: A Phase II-Study


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

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Trial Information

Allogeneic Stem Cell Transplantation From Unrelated Donors After Dose-Reduced Intensity Conditioning Regimen for Patients With Multiple Myeloma and Relapse After Autologous Stem Cell Transplantation: A Phase II-Study


Inclusion Criteria:



- Multiple Myeloma stage II or III acc. to Salmon and Durie (chemosensitive or
refractory) and relapse or progression after high dose chemotherapy with autologous
stem cell support

- Age 18-60 years

- ECOG-performance status 0-1

- Availability of a HLA-compatible unrelated donor (HLA-A, -B, -DRB1, -DQB1)

Exclusion Criteria:

- Serious concomitant medical disease that would limit life span or ability to tolerate
chemotherapy

- Severe cardiac failure (ejection fraction < 40%)

- Severe impairment of renal function (Creatinine clearance < 50ml/min)

- Severe impairment of liver function (bilirubine > 2 fold of upper limits of normal)

- Pregnant or lactating women

- Other major organ or system dysfunctions(GI, neurological, psychiatric dysfunctions
that would impair tolerance of chemotherapy or prolonged haematological recovery)

- Positivity for HIV

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Engraftment, chimerism, toxicity, non-relapse mortality

Outcome Time Frame:

Follow-up until day +1095

Safety Issue:

Yes

Principal Investigator

Nicolaus Kroeger, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinikum Hamburg-Eppendorf

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EBMT MUDRIC-MM

NCT ID:

NCT00599495

Start Date:

November 2002

Completion Date:

October 2011

Related Keywords:

  • Multiple Myeloma
  • Hematopoietic Stem Cell Transplantation
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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