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

Launched by PHARMACOSMOS A/S · Sep 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different substances, pentaisomaltose and dimethyl sulphoxide, to see which one better protects stem cells during a specific medical procedure called autologous stem cell transplantation (ASCT) for patients with multiple myeloma or malignant lymphoma. In this trial, participants will receive one of these substances to help ensure their stem cells are safe during the freezing and thawing process, which is crucial for their treatment.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of multiple myeloma or malignant lymphoma that requires ASCT. They must also be willing to stay in the hospital for at least 24 hours after the procedure. Participants will be closely monitored throughout the trial, and they will need to sign a consent form to confirm their willingness to take part. It’s important to note that certain conditions, like severe infections or previous stem cell treatments, may prevent someone from joining the trial. This study is not yet recruiting participants, but it aims to help improve future treatments for patients facing these serious conditions.

Gender

ALL

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