Allogeneic natural killer cell therapy in multiple myeloma patients

Phase 1

Recruiting

• Conditions: Multiple myeloma.; Multiple myeloma; C90.0

• Registration Number: IRCT20230801058996N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

The presence of at least one of the followings: more than 0.5 g/dl M-protein in serum protein electrophoresis, excretion of at least 200 mg of M-protein in urine, more than 10 mg/dL immunoglobulin free light chain in serum
Relapse confirmation based on International Myeloma Working Group
Refractory to at least two treatment regimens (an immunomodulatory drug, a proteasome inhibitor drug)
High-risk multiple myeloma according to the International Myeloma Working Group: recurrence within 12 months after the previous autologous transplant or progression of the disease within 1 year since the diagnosis of the disease or the presence of any of the high-risk cytogenetic cases including t(4;14), t (14;16), (14;20)t, chromosome gain/amplification (+1q21), deletion of the short arm of chromosome 17 (del(17p))

Exclusion Criteria

Insufficiency of engraftment parameters: WBC less than1000/µl, Platelets less than 20000/µl, Hemoglobin less than 8g/dL
Total bilirubin greater than 2mg/dL
Creatinine greater than 2mg/dL
Renal clearance less than 30 mL/min
Liver enzymes more than 2.5 times the upper limit of normal

Study & Design

• Study Type: interventional
• Study Design: Not specified