Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00777998
First received: October 22, 2008
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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 >55 years, followed by maintenance therapy with low-dose Thalidomide and Donor Lymphocyte Infusions.


Condition Intervention Phase
Multiple Myeloma
Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < 55 Years: A Phase II-study

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of acute GvHD [ Time Frame: day +100 after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
  • Incidence of chronic GvHD [ Time Frame: at one year and at two years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
  • Toxicity of conditioning regimen and of maintenance therapy [ Time Frame: Throughout conditioning regimen and maintenance therapy ] [ Designated as safety issue: Yes ]
  • cumulative incidence of relapse [ Time Frame: four years after Tandem stem cell transplantation ] [ Designated as safety issue: Yes ]
  • Disease related mortality [ Time Frame: four years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
  • Treatment related mortality [ Time Frame: four years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: four years after allogeneic stem cell transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: August 2008
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI
Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI

*Multiple myeloma

  • -> Induction Therapy (max. 8 cycles)
  • -> Registration of patient, stem cell mobilization, start of donor search
  • -> Melphalan (200mg/qm) plus autologous PBSCT
  • -> 2 months later: Melphalan plus allogeneic PBSCT
  • -> day 120 after allogeneic PBSCT: Thalidomide, 100mg (max. 2 years or until progress or non-tolerable toxicity, respectively)
  • -> day 180 after allogeneic PBSCT (if CsA discontinued): First DLI (1 x 10^6 (MRD) or 5 x 10^5 (MUD) CD3+ cells per kg BW)
  • -> day 250 after allogeneic PBSCT: second DLI (if no signs of GvHD: dose escalation by 0,5 Log)
  • -> Day 320 after allogeneic PBSCT: Third DLI (if no signs of GvHD: dose escalation by 0,5 Log)
  • -> Further DLI depending on MRD-measurement
Active Comparator: B
Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide

*Multiple myeloma

  • -> Induction Therapy (max. 8 cycles)
  • -> Registration of patient, stem cell mobilization, start of donor search
  • -> Melphalan (200mg/qm) plus autologous PBSCT
  • -> if no donor available (max 4 weeks after autologous PBSCT) or if patients declines allogeneic PBSCT): 2 months: Melphalan (200mg/qm) plus autologous PBSCT
  • -> day 120 after autologous PBSCT: Thalidomide, 100mg (max. 2 years or until progress or non-tolerable toxicity, respectively)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple Myeloma Stage II or III acc. to Salmon and Durie
  • Patient's age 18-55 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 > 56 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777998

Contacts
Contact: Nicolaus Kroeger, Prof. Dr. +49-40-42803-5864 nkroeger@uke.uni-hamburg.de
Contact: Marion Heinzelmann +49-40-42803-4188 mheinzel@uke.uni-hamburg.de

Locations
Germany
Klinikum Augsburg Recruiting
Augsburg, Germany, 86156
Contact: Christoph Schmid, Dr.         
Principal Investigator: Christoph Schmid, Dr.         
Charité Not yet recruiting
Berlin, Germany, 12203
Contact: Lutz Uharek, Prof. Dr.         
Principal Investigator: Lutz Uharek, Prof. Dr.         
Universitätsklinikum Dresden Not yet recruiting
Dresden, Germany, 01307
Contact: Martin Bornhäuser, Prof. dr.         
Principal Investigator: Martin Bornhäuser, Prof. Dr.         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Contact: Guido Kobbe, PD Dr.         
Principal Investigator: Guido Kobbe, PD Dr.         
Universitätsklinikum Erlangen Not yet recruiting
Erlangen, Germany, 91054
Contact: Wolf Rösler, Dr.         
Principal Investigator: Wolf Rösler, Dr.         
Universitätsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Dietrich W. Beelen, Prof. Dr.         
Principal Investigator: Dietrich W. Beelen, Prof. Dr.         
Klinikum Frankfurt (Oder) GmbH Not yet recruiting
Frankfurt (Oder), Germany, 15236
Contact: Michael Kiehl, Prof. Dr.         
Principal Investigator: Michael Kiehl, Prof. Dr.         
Universitätsklinikum Greifswald Not yet recruiting
Greifswald, Germany, 17475
Contact: Gottfried Dölken, Prof. Dr.         
Principal Investigator: Gottfried Dölken, Prof. dr.         
Universitätsklinikum Göttingen Not yet recruiting
Göttingen, Germany, 37075
Contact: Gerald Wulf, Prof. Dr.         
Principal Investigator: Gerald Wulf, Prof. Dr.         
Universitätsklinikum Halle (Saale) Recruiting
Halle (Saale), Germany, 06097
Contact: Hans-Heinrich Wolf, Dr.         
Principal Investigator: Hans-Heinrich Wolf, Dr.         
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Contact: Hans J. Salwender, Dr.         
Principal Investigator: Hans J. Salwender, Dr.         
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Nicolaus Kroeger, Prof. Dr.    +49-40-42803-5684    nkroeger@uke.uni-hamburg.de   
Contact: Marion Heinzelmann    +49-40-42803-4188    mheinzel@uke.uni-hamburg.de   
Principal Investigator: Nicolaus Kröger, Prof. Dr.         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Dietrich Peest, Prof. Dr.         
Principal Investigator: Dietrich Peest, Prof. Dr.         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Ute Hegenbart, Dr.         
Principal Investigator: Ute Hegenbart, Dr.         
Universitätsklinikum Marburg Not yet recruiting
Marburg, Germany, 35032
Contact: Andreas Neubauer, Prof. Dr.         
Principal Investigator: Andreas Neubauer, Prof. Dr.         
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: Joachim Kienast, Prof. Dr.         
Principal Investigator: Joachim Kienast, Prof. Dr.         
Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Walter E. Aulitzky, Prof. Dr.         
Principal Investigator: Walter E. Aulitzky, Prof. Dr.         
Universitätsklinikum Tübingen Not yet recruiting
Tübingen, Germany, 72076
Contact: Wolfgang Bethge, PD Dr.         
Principal Investigator: Wolfgang Bethge, PD Dr.         
Deutsche Klinik für Diagnostik Recruiting
Wiesbaden, Germany, 65191
Contact: Rainer Schwerdtfeger, PD Dr.         
Principal Investigator: Rainer Schwerdtfeger, PD Dr.         
Horst Schmidt Kliniken GmbH Recruiting
Wiesbaden, Germany, 65199
Contact: Norbert Frickhofen, Prof. Dr.         
Principal Investigator: Norbert Frickhofen, Prof. Dr.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00777998     History of Changes
Other Study ID Numbers: Auto-Allo TSCT in MM
Study First Received: October 22, 2008
Last Updated: May 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Multiple Myeloma
Stem Cell Transplantation
Thalidomide
DLI

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014