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

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

allogeneic HSCT

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Hematopoietic Stem Cell Transplantation, Multiple Myeloma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

University Medical Center Hamburg-Eppendorf

Outcomes

Primary Outcome Measures

Engraftment, chimerism, toxicity, non-relapse mortality

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.

Full Information

NCT ID

NCT00599495

First Posted

January 11, 2008

Last Updated

September 1, 2022

Sponsor

Universitätsklinikum Hamburg-Eppendorf

1. Study Identification

Unique Protocol Identification Number

NCT00599495

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee

5. 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.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Hematopoietic Stem Cell Transplantation, Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

allogeneic HSCT

Intervention Description

dose-reduced conditioning regimen

Primary Outcome Measure Information:

Title

Engraftment, chimerism, toxicity, non-relapse mortality

Time Frame

Follow-up until day +1095

Secondary Outcome Measure Information:

Title

Time Frame

Follow-up until day +1095

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolaus Kroeger, Prof. Dr.

Organizational Affiliation

Universitätsklinikum Hamburg-Eppendorf

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

19912215

Citation

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.

Results Reference

result

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

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