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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

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 < _60 Years: A Phase II-study
Actual Study Start Date : October 14, 2008
Actual Primary Completion Date : April 17, 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of acute GvHD [ Time Frame: day +100 after allogeneic stem cell transplantation ]
  2. Incidence of chronic GvHD [ Time Frame: at one year and at two years after allogeneic stem cell transplantation ]
  3. Toxicity of conditioning regimen and of maintenance therapy [ Time Frame: Throughout conditioning regimen and maintenance therapy ]
  4. cumulative incidence of relapse [ Time Frame: four years after Tandem stem cell transplantation ]
  5. Disease related mortality [ Time Frame: four years after allogeneic stem cell transplantation ]
  6. Treatment related mortality [ Time Frame: four years after allogeneic stem cell transplantation ]
  7. overall survival [ Time Frame: four years after allogeneic stem cell transplantation ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777998


Locations
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Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Nicolaus Kroeger, Prof. Dr. University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
More Information
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00777998    
Other Study ID Numbers: Auto-Allo TSCT in MM
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Multiple Myeloma
Stem Cell Transplantation
Thalidomide
DLI
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Ferrous fumarate
 Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Trace Elements
Micronutrients
Nutrients