Expanded Natural Killer (NK) Cells for Multiple Myeloma Study

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: Treatment with in vitro expanded haploidentical NK cells

• Registration Number: NCT01040026
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

High-dose chemotherapy with melphalan and autologous hematopoietic stem cell transplantation (HSCT) is considered standard treatment for patients with multiple myeloma. While autologous HSCT may induce remission in patients resistant to standard chemotherapy, and has been shown to lead to long-lasting disease control in a subgroup of patients, the procedure is not curative. Given enough time and in the absence of a competing cause of death, all patients eventually relapse after auto-HSCT.

The only potentially curative approach currently available in the treatment of multiple myeloma (MM) is stem cell trans-plantation from an allogeneic donor. Allogeneic HSCT eradicates residual myeloma cells through T-cell mediated graft-versus-tumor effects. Allogeneic HSCT is, however, associated with significant risk of graft-versus-host disease and its use is therefore limited to younger patients with high risk dis-ease. Malignant plasma cells in multiple myeloma are also sensitive to natural killer cell lysis. Natural killer cells do not cause graft-versus-host disease, which has led to interest in their therapeutic use in patients with multiple myeloma.

We have previously shown that immunomagnetic separation of a highly pure NK cell product from a leukapheresis is possible and that these cells can be expanded up to 100-fold in a GMP-compatible setting. The current study aims to test the tolerability and feasibility of infusions of in vitro expanded haploidentical NK cells for patients after melphalan 200mg/m2 high dose chemotherapy and autologous HSCT in 10 patients. If feasible, the data will provide a basis for further prospective studies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-25
• Study Start: 2012-10
• Primary Completion: 2016-09
• Study Completion: 2020-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• > 18 years, with multiple myeloma and indication for an autologous HSCT
• Available related haploidentical donor
• Written informed consent

Exclusion Criteria

• Patients scheduled for autologous/allogeneic tandem HSCT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NK cell infusions	Treatment with in vitro expanded haploidentical NK cells	10 NK cell infusions day 3-30; Treatment with in vitro expanded haploidentical NK cells

Primary Outcome Measures

Name	Time	Method
Safety of expanded NK cell infusion	One year after infusion.

Secondary Outcome Measures

Name	Time	Method
Treatment efficacy	One year after treatment

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Basel, BS, Switzerland