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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01729091|
Recruitment Status : Recruiting
First Posted : November 20, 2012
Last Update Posted : March 20, 2018
The goal of this clinical research study is to learn if adding NK cells will help make the stem cell transplant more effective in treating the disease. The safety of this treatment will also be studied.
NK cells may kill myeloma cells that remain in your body after your last chemotherapy treatment. The NK cells are separated from the umbilical cord blood sample. These separated NK cells will then be "grown" (manipulated) in the lab to increase the number of NK cells that can be given to you by vein.
Elotuzumab is designed to directly activate NK cells, that may help kill myeloma cells.
Lenalidomide (Revlimid) is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die.
Melphalan is designed to attach to the DNA (genetic material) of cells, which may cause cancer cells to die. It is commonly used in stem cell transplantation.
This is an investigational study. The way researchers make the NK cells is investigational. At this time, it is being used in research only. The NK cell preparation will be provided at no cost to you.
Lenalidomide is FDA approved and commercially available to treat patients with multiple myeloma who have received at least 1 prior therapy.
Melphalan is commercially available and FDA approved for the treatment of myeloma.
Up to 60 participants will be enrolled in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Drug: Lenalidomide Drug: Melphalan Procedure: NK Cell Infusion Procedure: Stem Cell Infusion Drug: G-CSF Drug: Elotuzumab Drug: Dexamethasone||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: Chemotherapy + NK and Stem Cell Infusions
Part I Dose Escalation: From Day -8 to Day -2, lenalidomide 10 mg by mouth daily. On Day -7, high-dose melphalan 200 mg/m^2 by vein. On D-5 NK cell given by vein. On Day 0, autologous stem cell infusion minimum cell dose of 1 x 10^8 cells/kg. G-CSF 5 mcg/kg/day subcutaneously beginning on Day 0, and continuing until evidence of an absolute neutrophil count (ANC) of 0.5 * 109/L per 3 consecutive days.
Elotuzumab 10 mg/kg to be given on day -15 (out-patient) and day -8 (in-patient). Dexamethasone 28 mg by mouth 3 to 24 hours before Elotuzumab infusion plus 8 mg by vein 45 to 90 minutes prior to infusion.
Part I Dose Expansion: Additional 18 high-risk patients treated.
10 mg by mouth daily Day -8 to Day -2.
200 mg/m^2 by vein on Day -7.
Other Name: Alkeran
Procedure: NK Cell Infusion
Part I Dose Escalation: Starting dose of Natural Killer (NK) cells 1 x 10^8 cells/kg infused on Day -5.
Part II Dose Expansion: Dose of Natural Killer (NK) cells is MTD from Part I Dose Escalation.
Procedure: Stem Cell Infusion
Autologous stem cell infusion minimum cell dose of 2 e6 cells/kg on Day 0.
5 mcg/kg/day subcutaneously on Day 0, and continuing until evidence of an absolute neutrophil count (ANC) of 0.5 x 109/L per 3 consecutive days.
10 mg/kg by vein to be given on day -15 (out-patient) and day -8 (in-patient).
28 mg by mouth 3 to 24 hours before Elotuzumab infusion plus 8 mg by vein 45 to 90 minutes prior to infusion.
Other Name: Decadron
- Maximum Tolerated Dose (MTD) of umbilical cord blood (UCB)-derived natural killer (NK) cells [ Time Frame: 30 Days ]Maximum tolerated dose (MTD) of UCB-derived NK cells defined as highest dose for which the probability of toxicity is closest to 20%. Dose limiting toxicity (DLT) defined as biopsy proven acute graft versus host disease (GvHD) with overall grade 3 as assessed based on modified Keystone criteria; failure to engraft; or grade 3-4 infusional toxicity of the NK cells.
- Minimal Residual Disease (MRD) Negative r\Rate 100 days Post-Transplant [ Time Frame: 100 days post-transplant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729091
|Contact: Rohtesh Mehta, MD, MS, MPH||713-745-9669|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rohtesh Mehta, MD, MS, MPH||M.D. Anderson Cancer Center|