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AzTrials

Multiple MyelomaPhase 2NCT00777998

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

A Phase 2 study testing Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI and auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 20 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI and auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
20 sitesGermany
Study dates
14 Oct 2008to Jun 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Germany20 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Charité

    Berlin, 12203

  • Universitätsklinikum Dresden

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, 45122

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236

  • Universitätsklinikum Göttingen

    Göttingen, 37075

  • Universitätsklinikum Greifswald

    Greifswald, 17475

  • Universitätsklinikum Halle (Saale)

    Halle, 06097

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Marburg

    Marburg, 35032

  • Universitätsklinikum Münster

    Münster, 48149

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191

  • Horst Schmidt Kliniken GmbH

    Wiesbaden, 65199

Other trials in Germany

About this study

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

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.

Being tested
Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI, auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Keywords
Multiple Myeloma, Stem Cell Transplantation, Thalidomide, DLI
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLIProcedure or surgery

    *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

  • auto-auto Tandem stem cell transplantation and maintenance therapy with ThalidomideProcedure or surgery

    *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 groups in NCT00777998
Study groupRoleWhat they receive
AExperimentalAuto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI
Receives: Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
BActive comparatorAuto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
Receives: Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: four years after Tandem stem cell transplantation

Secondary outcomes (7)

  1. Incidence of acute GvHD

    Measured: day +100 after allogeneic stem cell transplantation

  2. Incidence of chronic GvHD

    Measured: at one year and at two years after allogeneic stem cell transplantation

  3. Toxicity of conditioning regimen and of maintenance therapy

    Measured: Throughout conditioning regimen and maintenance therapy

  4. cumulative incidence of relapse

    Measured: four years after Tandem stem cell transplantation

  5. Disease related mortality

    Measured: four years after allogeneic stem cell transplantation

  6. Treatment related mortality

    Measured: four years after allogeneic stem cell transplantation

  7. overall survival

    Measured: four years after allogeneic stem cell transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2008 (estimated)
  2. Study start14 Oct 2008
  3. Primary completion17 Apr 2018
  4. Study completionJun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00777998
Sponsor's protocol ID
Auto-Allo TSCT in MM
Status last verified
Oct 2023
First submitted
22 Oct 2008
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
No

Publications

  • Kroger N, Wulf G, Hegenbart U, Burchert A, Stelljes M, Gagelmann N, Brecht A, Kaufmann M, Muller L, Ganser A, Wolf D, Bethge W, Bornhauser M, Kiehl M, Wagner EM, Schmid C, Reinhardt HC, Kobbe G, Salwender H, Heinicke T, Kropff M, Heinzelmann M, Ayuk F, Trumper L, Neubauer A, Volp A, Kluychnikov E, Schonland S, Wolschke C. Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective, phase II study. Haematologica. 2024 May 1;109(5):1469-1479. doi: 10.3324/haematol.2023.282920.

    PubMed 37941409

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI and auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 20 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00777998, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.

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