Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma
NCT02481934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2021-08-20
Summary
The purpose of this study is to determine wether activated and expanded autologous Natural Killer cells (NKAEs) are effective in the treatment of patients with multiple myeloma on second or later relapse. NKAEs are used in combination with anti-myeloma drugs such as lenalidomide or bortezomib.
Conditions
Interventions
- PROCEDURE
-
NKAE cells infusion
Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.
- DRUG
-
Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
- DRUG
-
Bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.
Sponsors & Collaborators
-
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
collaborator OTHER -
Joaquín Martínez López, MD, PhD
lead OTHER
Principal Investigators
-
Joaquín Martínez López, M.D, Ph.D · Hospital Universitario 12 de Octubre
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2016-07-31
- Completion
- 2016-10-31
Countries
- Spain
Study Locations
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