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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Stem Cell Transplantation, Thalidomide, DLI

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Augsburg
  • Charité
  • Universitätsklinikum Dresden
  • Universitätsklinikum Düsseldorf
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Essen
  • Klinikum Frankfurt (Oder) GmbH
  • Universitätsklinikum Greifswald
  • Universitätsklinikum Göttingen
  • Universitätsklinikum Halle (Saale)
  • University Medical Center Hamburg-Eppendorf
  • Asklepios Klinik Altona
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Marburg
  • Universitätsklinikum Münster
  • Robert-Bosch-Krankenhaus
  • Universitätsklinikum Tübingen
  • Deutsche Klinik für Diagnostik
  • Horst Schmidt Kliniken GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI

Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide

Outcomes

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.

Secondary Outcome Measures

Incidence of acute GvHD
Incidence of chronic GvHD
Toxicity of conditioning regimen and of maintenance therapy
cumulative incidence of relapse
Disease related mortality
Treatment related mortality
overall survival

Full Information

First Posted
October 22, 2008
Last Updated
May 3, 2018
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT00777998
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2008 (Actual)
Primary Completion Date
April 17, 2018 (Actual)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Stem Cell Transplantation, Thalidomide, DLI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI
Arm Title
B
Arm Type
Active Comparator
Arm Description
Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
Intervention Type
Procedure
Intervention Name(s)
Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
Intervention Description
*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
Intervention Type
Procedure
Intervention Name(s)
auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Intervention Description
*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)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of acute GvHD
Time Frame
day +100 after allogeneic stem cell transplantation
Title
Incidence of chronic GvHD
Time Frame
at one year and at two years after allogeneic stem cell transplantation
Title
Toxicity of conditioning regimen and of maintenance therapy
Time Frame
Throughout conditioning regimen and maintenance therapy
Title
cumulative incidence of relapse
Time Frame
four years after Tandem stem cell transplantation
Title
Disease related mortality
Time Frame
four years after allogeneic stem cell transplantation
Title
Treatment related mortality
Time Frame
four years after allogeneic stem cell transplantation
Title
overall survival
Time Frame
four years after allogeneic stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Charité
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitätsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum Frankfurt (Oder) GmbH
City
Frankfurt (Oder)
ZIP/Postal Code
15236
Country
Germany
Facility Name
Universitätsklinikum Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitätsklinikum Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle (Saale)
ZIP/Postal Code
06097
Country
Germany
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Marburg
City
Marburg
ZIP/Postal Code
35032
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Deutsche Klinik für Diagnostik
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Horst Schmidt Kliniken GmbH
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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