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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
Sponsor:
Collaborator:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Information provided by (Responsible Party):
Joaquín Martínez López, MD, PhD, Hospital Universitario 12 de Octubre

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Procedure: NKAE cells infusion
Drug: Lenalidomide
Drug: Bortezomib
Enrollment 5
Recruitment Details Recruitment was performed between march 2013 and october 2014 at Hospital 12 de Octubre in Madrid.
Pre-assignment Details  
Arm/Group Title NKAE Cells Infusion + Chemotherapy
Hide Arm/Group Description

Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).

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: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.

Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.

Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Reason Not Completed
Death             2
Arm/Group Title NKAE Cells Infusion + Chemotherapy
Hide Arm/Group Description

Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).

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: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.

Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
The number of participants was directly related with the cost of expanded and activated NK cells production.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 5 participants
62
(61 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 5 participants
5
1.Primary Outcome
Title Number of Participants With Adverse Events During NKAE Treatment
Hide Description 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.
Time Frame 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol
Arm/Group Title NKAE Cells Infusion + Chemotherapy
Hide Arm/Group Description:

Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).

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: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.

Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization
Hide Description 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.
Time Frame 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NKAE Cells Infusion + Chemotherapy
Hide Arm/Group Description:

Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).

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: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.

Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
5
Time Frame 4 months during treatment with NKAE cells.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NKAE Cells Infusion + Chemotherapy
Hide Arm/Group Description

Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).

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: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.

Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.

All-Cause Mortality
NKAE Cells Infusion + Chemotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NKAE Cells Infusion + Chemotherapy
Affected / at Risk (%) # Events
Total   2/5 (40.00%)    
Gastrointestinal disorders   
Gastrointestinal bleeding * 1 [1]  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Vertebral compression * 1 [2]  1/5 (20.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 3.0
[1]
The patient was suffering for gastrointestinal bleeding before enrollment.
[2]
This serious adverse event was due to multiple myeloma bone lesions.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NKAE Cells Infusion + Chemotherapy
Affected / at Risk (%) # Events
Total   2/5 (40.00%)    
Immune system disorders   
Neutropenia  1 [1]  2/5 (40.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
[1]
Two patients had grade II neutropenia but none of them need dose adjustment.
Volume of the peripheral blood from patients was limiting in order to perform different cohorts with more NKAE cells infusions.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alejandra Leivas PhD
Organization: Hospital universitario 12 de octubre
Phone: +34917792612 ext 4612
EMail: alejandraleial@gmail.com
Layout table for additonal information
Responsible Party: Joaquín Martínez López, MD, PhD, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT02481934     History of Changes
Other Study ID Numbers: NK-VS-MM
First Submitted: June 10, 2015
First Posted: June 25, 2015
Results First Submitted: July 20, 2016
Results First Posted: December 5, 2016
Last Update Posted: April 17, 2017