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

NCT00599495 | Completed Phase 2

• 1 other identifier: EBMT MUDRIC-MM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Hematopoietic Stem Cell Transplantation; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Engraftment, chimerism, toxicity, non-relapse mortality

  Follow-up until day +1095

Secondary Outcomes (1)

• 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

Interventions

allogeneic HSCT PROCEDURE

dose-reduced conditioning regimen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 19912215 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nicolaus Kroeger, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: November 1, 2002
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

DE (1)