Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma (NK-VS-MM)
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|ClinicalTrials.gov Identifier: NCT02481934|
Recruitment Status : Completed
First Posted : June 25, 2015
Results First Posted : December 5, 2016
Last Update Posted : April 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Procedure: NKAE cells infusion Drug: Lenalidomide Drug: Bortezomib||Phase 1|
It is expected to enroll 10 to 15 patients within 18 months. Patients have to achieve stable disease after induction therapy. Peripheral blood from patients will be collected every cycle (n=4) to produce NKAEs under Good Manufacturing Practice (GMP) conditions peripheral blood mononuclear cell (PBMCs) will be co-cultured with a genetically modified cell line (K562-mb15-41BBL) and 100 IU/ml interleukin-2.
Treatment consists of 4 cycles of anti-myeloma consolidation treatment with two infusions of NKAEs every day 1 and 8 of each cycle. Usually, chosen treatment regime will be bortezomib (Velcade) or lenalidomide (Revlimid). These treatments are used to be combined with corticosteroid medications which needs to be suspended before NKAEs infusions. A washout period of 2 weeks is required.
NKAEs dose of cells will be constant, 7.5x106/kg. There will be an interim analysis intra-cohort one week after the first batch of two infusions. If at the analysis no grade IV adverse effect is observed we will proceed to the second cycle and the inclusion of other patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Clinical Trial to Evaluate Security and Dose of Expanded and Activated Autologous NK Cells Infusions in Consolidation of Multiple Myeloma Patients Treatment on Second or Later Relapse.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||October 2016|
Experimental: NKAE cells infusion + chemotherapy
Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).
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.
Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
Other Name: Revlimid
Bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.
Other Name: Velcade
- Number of Participants With Adverse Events During NKAE Treatment [ Time Frame: 16 months ]Toxicity will be assessed by adverse events count during NKAE treatment monitoring peripheral blood absolute neutrophil count (cells/μl). Toxicity will be evaluated monthly during NKAE treatment (4 months). During follow-up, it will be assessed monthly the first 6 months. After that, quarterly until one year of follow-up, based on Common Toxicity Criteria for Adverse Events of the National Cancer Institute (CTCAE) to v.4.03.
- Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization [ Time Frame: 16 months ]Efficacy will be assessed monthly during NKAE treatment (4 months) by peripheral blood monoclonal protein monitoring. During follow-up, efficacy will be evaluated monthly the first 6 months. After that, quarterly until one year of follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481934
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Principal Investigator:||Joaquín Martínez López, M.D, Ph.D||Hospital Universitario 12 de Octubre|