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

NCT ID: NCT00599495

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2009-12-31

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.

Detailed Description

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

allogeneic HSCT

dose-reduced conditioning regimen

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolaus Kroeger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

References

Kroger N, Shimoni A, Schilling G, Schwerdtfeger R, Bornhauser M, Nagler A, Zander AR, Heinzelmann M, Brand R, Gahrton G, Morris C, Niederwieser D, de Witte T. Unrelated stem cell transplantation after reduced intensity conditioning for patients with multiple myeloma relapsing after autologous transplantation. Br J Haematol. 2010 Jan;148(2):323-31. doi: 10.1111/j.1365-2141.2009.07984.x. Epub 2009 Nov 12.

Reference Type: RESULT

PMID: 19912215 (View on PubMed)

Other Identifiers

EBMT MUDRIC-MM

Identifier Type: -

Identifier Source: org_study_id