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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Completed

CT.gov ID

NCT00599495

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Procedure: allogeneic HSCT	Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Nov 1, 2002

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Engraftment, chimerism, toxicity, non-relapse mortality [Follow-up until day +1095]

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. [Follow-up until day +1095]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator: Nicolaus Kroeger, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT00599495

Other Study ID Numbers:

EBMT MUDRIC-MM

First Posted:

Jan 23, 2008

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Keywords provided by Universitätsklinikum Hamburg-Eppendorf

Hematopoietic Stem Cell Transplantation

Multiple Myeloma

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 25, 2022