Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < _60 Years: A Phase II-study

Universitätsklinikum Hamburg-Eppendorf20 sites in 1 country221 target enrollmentOctober 14, 2008

ConditionsMultiple Myeloma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Enrollment: 221
Locations: 20
Primary Endpoint: Event-free survival 4 years after auto-allo/ auto-auto Tandem-SCT. Any of the following will be considered an endpoint event: recurrence or progression of primary disease, disease related mortality, or treatment related mortality.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The present study will be a multicenter, prospective phase II-study investigating safety and efficacy of the combination of auto-allo tandem stem cell transplantation in patients with multiple myeloma and age of >_60 years, followed by maintenance therapy with low-dose Thalidomide and Donor Lymphocyte Infusions.

Registry

clinicaltrials.gov

Start Date

October 14, 2008

End Date

June 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Multiple Myeloma Stage II or III acc. to Salmon and Durie
•Patient's age 18-60 years
•Patient's written informed consent
•Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment
•a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)

Exclusion Criteria

•More than eight chemotherapy cycles prior to registration
•severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
•total bilirubin, SGPT or SGOT \> 3 times upper the normal level
•Left ventricular ejection fraction \< 30 %
•Creatinine Clearance \< 30 ml/min
•DLCO \< 35 % and/or receiving supplementary continuous oxygen
•Positive serology for HIV
•Pregnant or lactating women
•Participation in another trial at the time of registration
•Preceding autologous stem cell transplantation

Outcomes

Primary Outcomes

Event-free survival 4 years after auto-allo/ auto-auto Tandem-SCT. Any of the following will be considered an endpoint event: recurrence or progression of primary disease, disease related mortality, or treatment related mortality.

Time Frame: four years after Tandem stem cell transplantation

Secondary Outcomes

Incidence of acute GvHD(day +100 after allogeneic stem cell transplantation)
Treatment related mortality(four years after allogeneic stem cell transplantation)
cumulative incidence of relapse(four years after Tandem stem cell transplantation)
Toxicity of conditioning regimen and of maintenance therapy(Throughout conditioning regimen and maintenance therapy)
Incidence of chronic GvHD(at one year and at two years after allogeneic stem cell transplantation)
Disease related mortality(four years after allogeneic stem cell transplantation)
overall survival(four years after allogeneic stem cell transplantation)