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Trial Title:
Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma
NCT ID:
NCT01665014
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
autologous hematopoietic stem cell transplantation
total marrow irradiation
melphalan
multiple myeloma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Total marrow irradiation
Description:
Mobilization of stem cells with the use of cytarabine 1.6 g/m2 followed by filgrastim 480
ug/d. Conditioning for the 1st autoHSCT: total marrow irradiation 4 Gy on days -3,-2,-1
(total 12 Gy). Conditioning for 2nd autoHSCT performed 3-4 months after the 1st one:
melphalan 100 mg/m2 on days -2,-3 (total 200 mg/m2)
Arm group label:
Total marrow irradiation
Summary:
The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a
sole preparation for the first autologous hematopoietic stem cell transplantation
(autoHSCT) followed by high-dose melphalan used prior to second autoHSCT is safe and
effective in patients with multiple myeloma (MM).
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Address:
City:
Gliwice
Zip:
44-101
Country:
Poland
Contact:
Last name:
Sebastian Giebel, MD
Phone:
0048322788523
Email:
sgiebel@io.gliwice.pl
Investigator:
Last name:
Sebastian Giebel, MD
Email:
Principal Investigator
Start date:
August 2012
Completion date:
August 2016
Lead sponsor:
Agency:
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Agency class:
Other
Source:
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01665014
