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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05545202
• Other study ID #: P-Pentaisomaltose-CRYO-01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 30, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: April 2024
• Source: Pharmacosmos A/S
• Contact: Pharmacosmos A/S Clinical and Non-clinical Research
• Phone: +4559485959
• Email: info[@]pharmacosmos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 %

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Malignant Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Pentaisomaltose
Each subject will receive 1 or 2 bags with cryopreserved cells according to randomization group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engraftment of hematopoietic stem cells	Incidence of subjects with engraftment of hematopoietic stem cells, defined as 2 consecutive measurements with a neutrophil concentration >0.5×109/L within the first 19 days after ASCT	19 days
Primary	Incidence of subjects with AEs of special interest (limited)	Incidence of subjects with AEs of special interest (limited) occurring within 24 hours after ASCT: headache, nausea, vomiting, bradycardia, or unpleasant odor	24 hours after ASCT
Secondary	Incidence of subjects with AEs of special interest (limited)	Incidence of subjects with AEs of special interest (limited): headache, nausea, vomiting, bradycardia, or unpleasant odor	19 days
Secondary	Time to engraftment of neutrophil cells	• Time to engraftment of neutrophil cells, defined as 2 consecutive measurements with a neutrophil concentration >0.5×109/L within the first 19 days after ASCT	19 days