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

NCT05545202 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: P-Pentaisomaltose-CRYO-01
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Malignant Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Incidence of subjects with AEs of special interest (limited)

  19 days

• Time to engraftment of neutrophil cells

  19 days

Study Arms (2)

A: Pentaisomaltose 16 %

OTHER

Pentaisomaltose 40 % sterile solution; 40 mL will be transferred to a total volume of 100 mL, so the final concentration is 16 %.

Other: Pentaisomaltose

B: DMSO 10 %

ACTIVE COMPARATOR

Comparator: DMSO 99.9 % sterile solution; 10 mL will be transferred to a total volume of 100 mL, so the final concentration is 10 %.

Other: Pentaisomaltose

Interventions

Pentaisomaltose OTHER

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

A: Pentaisomaltose 16 %; B: DMSO 10 %

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Central Study Contacts

Pharmacosmos A/S Clinical and Non-clinical Research

CONTACT

+4559485959; info@pharmacosmos.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject, trial personnel, and Pharmacosmos personnel will be blinded to the CPA. Blinding will be obtained by shielding the blinded trial personnel from seeing the preparation of the CPA and having unblinded personnel not involved in any trial assessments (efficacy or safety) responsible for randomization, preparation, and accountability of the CPA. The CPA will not be labelled in a way that would reveal the content of the CPA for the blinded personnel or the subject. CPA accountability will be monitored by an unblinded CRA.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: April 30, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04