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Efficacy and Safety of Double Autologous Hematopoietic Stem Cell Transplantation With Sequential Use of Total Marrow Irradiation and High-dose Melphalan in Multiple Myeloma


Phase 2
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Efficacy and Safety of Double Autologous Hematopoietic Stem Cell Transplantation With Sequential Use of Total Marrow Irradiation and High-dose Melphalan in Multiple Myeloma


AutoHSCT is a standard treatment of patients with MM. According to soem clinical evidence
double autoHSCT provides survival advantage compared to a single procedure. Most frequently
used conditioning regimen consists pf high doses of melphalan (HD-MEL). In some studies it
was used in combination with total body irradiation (TBI), which, however was associated
with significant toxicity. In our center the standard procedure includes TBI as a single
treatment at 1st autoHSCT and HD-Mel at 2nd autoHSCT.

As in MM malignant plasma cells are localized almost exclusively in bone marrow there is
rationale to limit irradiation to bones. For this purpose in the current study we substitute
TBI with TMI. Additional boosts are provided for active sites of disease based on PET/CT
imaging. Our intention is to minimize toxicity while maintaining the treatment efficacy.


Inclusion Criteria:



- Age 18-65 years

- Diagnosis of multiple myeloma

- PR, VGPR or CR at inclusion

- Performance status WHO 0-1

- Written informed consent

Exclusion Criteria:

- Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine >1.5 upper normal
limit; LVEF <45%

- Active infection

- Unstable diabetes

- Psychiatric diseases

- History of high-dose chemotherapy or irradiation

- Second malignancy

- Pregnancy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

three years

Safety Issue:

No

Principal Investigator

Sebastian Giebel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

Authority:

Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study ID:

TMI MM1

NCT ID:

NCT01665014

Start Date:

August 2012

Completion Date:

August 2016

Related Keywords:

  • Multiple Myeloma
  • autologous hematopoietic stem cell transplantation
  • total marrow irradiation
  • melphalan
  • multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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