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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00599495

Enrollment

Registered

2008-01-23

Start date

2002-11-30

Completion date

2009-12-31

Last updated

2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Hematopoietic Stem Cell Transplantation, Multiple Myeloma

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

Interventions

PROCEDUREallogeneic HSCT

dose-reduced conditioning regimen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

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.	Follow-up until day +1095

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026