Trial Outcomes & Findings for Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma (NCT NCT02481934)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

5 participants

Primary outcome timeframe

16 months

Results posted on

2021-08-20

Participant Flow

Recruitment was performed between march 2013 and october 2014 at Hospital 12 de Octubre in Madrid.

Participant milestones

Participant milestones
Measure	NKAE Cells Infusion + Chemotherapy 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 Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	NKAE Cells Infusion + Chemotherapy 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 Study Death	2

Baseline Characteristics

Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NKAE Cells Infusion + Chemotherapy n=5 Participants 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.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Spain	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 months

Population: Analysis per protocol

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.

Outcome measures

Outcome measures
Measure	NKAE Cells Infusion + Chemotherapy n=5 Participants 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.
Number of Participants With Adverse Events During NKAE Treatment	2 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NKAE Cells Infusion + Chemotherapy n=5 Participants 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.
Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization	5 participants

Adverse Events

NKAE Cells Infusion + Chemotherapy

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NKAE Cells Infusion + Chemotherapy n=5 participants at risk 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.
Gastrointestinal disorders Gastrointestinal bleeding	20.0% 1/5 • Number of events 1 • 4 months during treatment with NKAE cells.
Musculoskeletal and connective tissue disorders Vertebral compression	20.0% 1/5 • Number of events 2 • 4 months during treatment with NKAE cells.

Other adverse events

Other adverse events
Measure	NKAE Cells Infusion + Chemotherapy n=5 participants at risk 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.
Immune system disorders Neutropenia	40.0% 2/5 • Number of events 2 • 4 months during treatment with NKAE cells.

Additional Information

Alejandra Leivas PhD

Hospital universitario 12 de octubre

Phone: +34917792612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place