Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-Reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCT

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by Universitätsklinikum Hamburg-Eppendorf. Recruitment status was Active, not recruiting

First Received on January 11, 2008. Last Updated on October 28, 2008 History of Changes

Sponsor:	Universitätsklinikum Hamburg-Eppendorf
Information provided by:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00599495

Purpose

The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation

Condition	Intervention	Phase
Multiple Myeloma	Procedure: allogeneic HSCT	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:

Engraftment, chimerism, toxicity, non-relapse mortality [ Time Frame: Follow-up until day +1095 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluation of response/GvHD/ infectious complications/ disease-free survival, Prognostic impact of cytogenetic, Evaluation of incidence and prognostic impact of molecular remission in patients with clinically complete remission. [ Time Frame: Follow-up until day +1095 ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	November 2002
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

dose-reduced conditioning regimen

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599495

Locations

Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator:

Nicolaus Kroeger, Prof. Dr.

Universitätsklinikum Hamburg-Eppendorf

More Information

No publications provided

Responsible Party:	Prof. N. Kroeger, European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier:	NCT00599495 History of Changes
Other Study ID Numbers:	EBMT MUDRIC-MM
Study First Received:	January 11, 2008
Last Updated:	October 28, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul-Ehrlich-Institut

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:

Hematopoietic Stem Cell Transplantation
Multiple Myeloma

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012