A Randomized, Comparative, Double-blind Trial of Pentaisomaltose and Dimethyl Sulphoxide for Cryoprotection of Hematopoietic Stem Cells in Subjects With Multiple Myeloma or Malignant Lymphoma With a Need for Autologous Transplantation
Malignant Lymphoma, Multiple Myeloma
About this trial
This is an interventional treatment trial for Malignant Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Men or women ≥ 18 years
- Multiple myeloma or malignant lymphoma diagnosis in which ASCT is indicated according to the standard procedures at the hospital
- Willing to be hospitalized for minimum 24 hours after the ASCT
- Willingness to participate and signing the ICF
Exclusion Criteria:
- Multiple myeloma or lymphoma invasion of the central nervous system
- Previous treatment with ASCT
- Severe infection
- Unsuitable for apheresis
- Unable to provide ≥3 bags with a cell concentration ≥2.0×106 CD34+ cells/kg bodyweight per bag during apheresis
- Pregnant or nursing women. To avoid pregnancy, women of childbearing potential have to use adequate contraception (e.g., intrauterine devices, hormonal contraceptives, or double barrier method) during the whole trial period and up to 1 year after the last ASCT
- Men, even if surgically sterilized, (i.e., status post vasectomy), who do not agree to practice effective barrier contraception during the entire trial period and through 6 months after the last ASCT, or agrees to completely abstain from heterosexual intercourse
- Any other medical condition which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Active Comparator
A: Pentaisomaltose 16 %
B: A combination of Pentaisomaltose 10 % and DMSO 2 %
C: DMSO 10 %
Pentaisomaltose 40 % sterile solution; 40 mL will be transferred to a total volume of 100 mL, so the final concentration is 16 %.
Combination of IMP and comparator: Pentaisomaltose 40 % sterile solution; 25 mL will be transferred to a total volume of 100 mL, so the final concentration is 10 %. DMSO 99.9 % sterile solution; 2 mL will be transferred to a total volume of 100 mL, so the final concentration is 2 %.
Comparator: DMSO 99.9 % sterile solution; 10 mL will be transferred to a total volume of 100 mL, so the final concentration is 10 %.