Combination therapy of natural killer cells and daratumumab in patients with multiple myeloma

Safety and efficacy of combination therapy with daratumumab and activated allogeneic natural killer cells in relapsed/refractory multiple myeloma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230801058996N9

Enrollment

Registered

2026-05-17

Start date

2027-01-21

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma. Multiple myeloma

Interventions

Intervention group: In this study, patients with treatment-resistant multiple myeloma who have received daratumumab (Darzalex) alone and have not shown a satisfactory response will be enrolled in the

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Multiple myeloma patients with a history of receiving daratumumab alone and not responding to treatment Estimated life expectancy is more than 6 months Karnofsky status is above 70% Creatinine clearance rate is above 30 ml per minute Normal liver enzymes and liver function ECOG performance status is less than or equal to 1

Exclusion criteria

Exclusion criteria: Unrecovered from the side effects of autologous transplantation (toxicity greater than grade 2 in any organ) Inadequate engraftment parameters: WBC < 2500/mm3 and platelets < 50000/mm3 Radiation therapy, chemotherapy or immunotherapy starting 1 week before NK cell infusion and continuing 2 weeks after NK cell infusion Inherent impairment of organ function Physical or psychological conditions that place the patient at risk of toxicity or non-compliance Uncontrolled and life-threatening infections Concomitant treatment with corticosteroids and/or other immunosuppressive drugs

Design outcomes

Primary

Measure	Time frame
The adverse effects during or after combination therapy with allogeneic NK cells and daratumumab. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Patient statements and medical examinations in patient visits to bone marrow transplantation clinic for follow-up, Safety criteria are based on CTCAE (Common Terminology Criteria for Adverse Events) for side effects.;Response to teatment based on criteria defined by the International Multiple Myeloma Working Group (IMWG). Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient examinations at the bone marrow transplant clinic for follow-up and based on criteria defined by the International Multiple Myeloma Working Group (IMWG).	—

Measure

Time frame

The adverse effects during or after combination therapy with allogeneic NK cells and daratumumab. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Patient statements and medical examinations in patient visits to bone marrow transplantation clinic for follow-up, Safety criteria are based on CTCAE (Common Terminology Criteria for Adverse Events) for side effects.;Response to teatment based on criteria defined by the International Multiple Myeloma Working Group (IMWG). Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient examinations at the bone marrow transplant clinic for follow-up and based on criteria defined by the International Multiple Myeloma Working Group (IMWG).

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Secondary

Measure	Time frame
Event free survival. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients.;Progression free survival. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients.;Overall survival. Timepoint: From the first dose of NK cells infusion until six months afer its last dose. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients.	—

Measure

Time frame

Event free survival. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients.;Progression free survival. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients.;Overall survival. Timepoint: From the first dose of NK cells infusion until six months afer its last dose. Method of measurement: Regular patient visits to the bone marrow transplant clinic for follow-up and regular telephone monitoring of patients.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Roshandel

Shahid Beheshti University of Medical Sciences

elham.roshandel@gmail.com+98 21 2303 1490

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026