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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777998
Recruitment Status : Unknown
Verified May 2018 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was:  Active, not recruiting
First Posted : October 23, 2008
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE October 22, 2008
First Posted Date  ICMJE October 23, 2008
Last Update Posted Date May 4, 2018
Actual Study Start Date  ICMJE October 14, 2008
Actual Primary Completion Date April 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2008)
  • Incidence of acute GvHD [ Time Frame: day +100 after allogeneic stem cell transplantation ]
  • Incidence of chronic GvHD [ Time Frame: at one year and at two years after allogeneic stem cell transplantation ]
  • Toxicity of conditioning regimen and of maintenance therapy [ Time Frame: Throughout conditioning regimen and maintenance therapy ]
  • cumulative incidence of relapse [ Time Frame: four years after Tandem stem cell transplantation ]
  • Disease related mortality [ Time Frame: four years after allogeneic stem cell transplantation ]
  • Treatment related mortality [ Time Frame: four years after allogeneic stem cell transplantation ]
  • overall survival [ Time Frame: four years after allogeneic stem cell transplantation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 12, 2015)
221
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2008)
220
Estimated Study Completion Date  ICMJE June 2018
Actual Primary Completion Date April 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777998
Other Study ID Numbers  ICMJE Auto-Allo TSCT in MM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicolaus Kroeger, Prof. Dr. University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date May 2018

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