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

September 1, 2022 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Engraftment, chimerism, toxicity, non-relapse mortality
Time Frame: Follow-up until day +1095
Follow-up until day +1095

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Follow-up until day +1095

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBMT MUDRIC-MM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on allogeneic HSCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe