NCT05545202

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The trial is a randomized, comparative, double-blind trial comparing the efficacy and safety of pentaisomaltose (PentaHibe®, Pharmacosmos A/S, Holbæk; termed PIM in the following) and dimethyl sulphoxide (DMSO), when used for preservation of harvested hematopoietic stem cells. Approximately 150 subjects with a diagnosis of multiple myeloma or malignant lymphoma (a minimum of 30 % of each diagnosis and an equal distribution in each preservation group) and undergoing autologous stem cell transplantation (ASCT) will be included. The subjects will be randomized 1:1 to receive ASCT preserved in the following cryo-protective agent (CPA): * A: PIM 16 % * B: DMSO 10 %

Conditions

• Malignant Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	Pentaisomaltose	Each subject will receive 1 or 2 bags with cryopreserved cells according to randomization group.

Timeline

• Start date: 2024-04-30
• Primary completion: 2025-02-15
• Completion: 2025-02-15
• First posted: 2022-09-19
• Last updated: 2024-04-03