Clinical trial NCT00777998: Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Stem Cell Transplantation
Thalidomide
DLI
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2008-10-23
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* age \> 61 years

Primary outcomes:
measure: 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.
timeFrame: four years after Tandem stem cell transplantation
Secondary outcomes:
measure: Incidence of acute GvHD
timeFrame: day +100 after allogeneic stem cell transplantation
measure: Incidence of chronic GvHD
timeFrame: at one year and at two years after allogeneic stem cell transplantation
measure: Toxicity of conditioning regimen and of maintenance therapy
timeFrame: Throughout conditioning regimen and maintenance therapy
measure: cumulative incidence of relapse
timeFrame: four years after Tandem stem cell transplantation
measure: Disease related mortality
timeFrame: four years after allogeneic stem cell transplantation
measure: Treatment related mortality
timeFrame: four years after allogeneic stem cell transplantation
measure: overall survival
timeFrame: four years after allogeneic stem cell transplantation
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charité
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt (Oder)
country: Germany
facility: Klinikum Frankfurt (Oder) GmbH
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald
city: Göttingen
country: Germany
facility: Universitätsklinikum Göttingen
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
city: Wiesbaden
country: Germany
facility: Horst Schmidt Kliniken GmbH
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
name: Nicolaus Kroeger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: