Trials / Recruiting
RecruitingNCT04558931
Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma
An Open, Randomised, Controlled, Phase II Trial of CellProtect in Combination With Isatuximab Antibody Versus Isatuximab Antibody Alone as Maintenance Treatment in Patients With Multiple Myeloma Undergoing High Dose Treatment
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- Sponsor
- Karolinska Institutet · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CellProtect | In vitro expanded and activated autologous NK cells |
| DRUG | Isatuximab | Naked immunoglobulin (Ig) G1 monoclonal antibody (mAb) that selectively binds to the human cell surface antigen molecule classified as cluster of differentiation (CD) 38 |
Timeline
- Start date
- 2021-06-02
- Primary completion
- 2027-12-31
- Completion
- 2032-12-31
- First posted
- 2020-09-22
- Last updated
- 2023-10-11
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT04558931. Inclusion in this directory is not an endorsement.