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NCT Number: NCT00777998

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinikum Augsburg, Augsburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI

Procedure

*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 Thalidomide

Procedure

*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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2018
Study completion
2021
First posted
Oct 23, 2008
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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