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

October 22, 2008
May 27, 2013
August 2008
May 2017   (final data collection date for primary outcome 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. [ Time Frame: four years after Tandem stem cell transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00777998 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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
  • 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)
  • Experimental: A
    Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI
    Intervention: Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
  • Active Comparator: B
    Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
    Intervention: Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
May 2017
May 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
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
Germany
 
NCT00777998
Auto-Allo TSCT in MM
Not Provided
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Not Provided
Universitätsklinikum Hamburg-Eppendorf
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP