NCT01729091

Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase II Study of Umbilical Cord Blood-Derived Natural Killer Cells in Conjunction With Elotuzumab, Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant for Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and best dose of umbilical cord blood-derived natural killer cells when given together with elotuzumab, lenalidomide, and high dose melphalan before autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Before transplant, stem cells are taken from patients and stored. Immunotherapy with monoclonal antibodies, such as elotuzumab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and melphalan, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving natural killer cells from donor umbilical cord blood before transplant may also kill myeloma cells that remain in the body after the last chemotherapy treatment. After treatment, stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Detailed description

PRIMARY OBJECTIVES: I. To find the maximum tolerated dose (MTD) of umbilical cord blood (UCB)-derived natural killer (NK) cells. II. To determine efficacy by the percent of patients achieving very good partial remission (VGPR) + complete remission (CR) at 3 months post-transplant. III. To assess the minimal residual disease rate 100 days post-transplant in high-risk patients. SECONDARY OBJECTIVE: I. To quantify duration of infused allogeneic donor UCB-derived NK cells in the recipient. OUTLINE: This is a dose-escalation study of UCB-derived NK cells. Patients receive elotuzumab intravenously (IV) over 2-5 hours on day -15 and -8, lenalidomide orally (PO) once daily (QD) on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0. After completion of study treatment, patients are followed up at 30, 60 and 100 days and 6 and 12 months.

Conditions

• Plasma Cell Leukemia
• Plasma Cell Myeloma

Interventions

Type	Name	Description
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo autologous stem cell transplant
BIOLOGICAL	Elotuzumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenalidomide	Given PO
DRUG	Melphalan	Given IV
BIOLOGICAL	Natural Killer Cell Therapy	Given IV
BIOLOGICAL	Umbilical Cord Blood-Derived Lymphocyte Therapy	Given IV

Timeline

• Start date: 2013-06-10
• Primary completion: 2024-06-25
• Completion: 2024-06-25
• First posted: 2012-11-20
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study