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New treatment option for Multiple Myeloma
Official title Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma
ClinicalTrials.gov ID: NCT04558931
What this study is testing
What is CellProtect?
CellProtect is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Also referred to as Autologous NK cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prospective, single center, randomized, open label, parallel group, 2-arm study assessing the clinical benefit in term of enhancement of overall response rate of Isatuximab in combination with CellProtect as compared to Isatuximab for the treatment of patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) as maintenance after SCT.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- I1. Active multiple myeloma, as defined by the IMWG criteria. I2. Evidence of measurable disease: I3. Serum monoclonal (M)-protein ≥1.0 g/dL measured...
- Male participants A male participant must agree to use contraception of this protocol during the intervention period and for at least 5 months after...
- Female participants A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following...
You likely can't join if
- E1. Prior or concurrent exposure to NK cells and NK like T cells, or Approved or investigational treatments for MM.
- E2. Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- E3. Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma (asymptomatic multiple...
- E4. Diagnosis of Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration...
- E5. Prior or current systemic therapy, or SCT for symptomatic multiple myeloma, with the exception of an emergency use of a short course (equivalent...
- E6. Concomitant plasma cell leukemia. E7. Any major procedure within 14 days before the initiation of the study treatment: plasmapheresis, major...
See the full eligibility criteria
- I1. Active multiple myeloma, as defined by the IMWG criteria. I2. Evidence of measurable disease: I3. Serum monoclonal (M)-protein ≥1.0 g/dL measured using serum protein immunoelectrophoresis a.and/or I4. Urine...
- Male participants A male participant must agree to use contraception of this protocol during the intervention period and for at least 5 months after the last dose of study treatment and refrain from donating sperm...
- Female participants A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a Females of childbearing potential (FCBP), OR A...
- E1. Prior or concurrent exposure to NK cells and NK like T cells, or Approved or investigational treatments for MM.
- E2. Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- E3. Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ...
- E4. Diagnosis of Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
- E5. Prior or current systemic therapy, or SCT for symptomatic multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids, if...
- E6. Concomitant plasma cell leukemia. E7. Any major procedure within 14 days before the initiation of the study treatment: plasmapheresis, major surgery (kyphoplasty is not considered a major procedure), radiotherapy...
- E8. ECOG PS \>2. E9. Hemoglobin \<8 g/dL. E10. Platelets \<70 × 109/L if \<50% of bone marrow (BM) nucleated cells are plasma cells, and ≤30 × 109/L if ≥50% of BM nucleated cells are plasma cells. Platelet transfusion...
- E11. Total bilirubin \>1.5 × upper limit of normal (ULN), except for known Gilbert syndrome.
- E12. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3 × ULN.
- E13. Hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components of study therapy that are not amenable to...
- E14. Any of the following within 6 months prior to randomization:
- E15. Second/third degree heart block E16. Poorly controlled hypertension E17. Myocardial infarction E18. Severe/unstable angina pectoris E19. Coronary/peripheral artery bypass graft E20. New York Heart Association class...
- E25. Known acquired immunodeficiency syndrome (AIDS)-related illness or known HIV disease requiring antiviral treatment or active hepatitis A (defined as positive HA antigen), B (defined as either positive HBs antigen...
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.