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Trial 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
NCT ID:
NCT05545202
Condition:
Malignant Lymphoma
Multiple Myeloma
Conditions: Official terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
Pentaisomaltose
Description:
Each subject will receive 1 or 2 bags with cryopreserved cells according to randomization
group.
Arm group label:
A: Pentaisomaltose 16 %
Arm group label:
B: DMSO 10 %
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 %
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 30, 2024
Completion date:
February 15, 2025
Lead sponsor:
Agency:
Pharmacosmos A/S
Agency class:
Industry
Source:
Pharmacosmos A/S
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05545202
