Cord Blood Natural Killer Cells for Myeloma

Overview

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. Drugs used in chemotherapy, such as elotuzumab, 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.

SparkCures ID 74
Trial Phase Phase 1/2
Enrollment 18 Patients
Treatments
Trial Sponsors
  • MD Anderson Cancer Center
Trial Collaborators
  • Celgene Corporation
NCT Identifier

NCT01729091

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  1. Patients with high risk multiple myeloma who are transplant candidates, in partial response (PR) or better. High risk will be defined as patients with any of the following: a. Fluorescence in situ hybridization showing t(4:14), t(14:16)t (14:20 deletion (Del) 17/17p or gain (amp) 1q; b. Deletion 13 by conventional cytogenetic analysis; c. High risk signatures as determined by the GEP-70 or EMC-92 gene expression profiles; d. Relapsed disease within 18 months of prior ASCT.
  2. Patients with plasma cell leukemia who are transplant candidates.
  3. 18 to 75 years of age.
  4. Performance score of at least 70% by Karnofsky or 0 to 2 ECOG.
  5. Adequate major organ system function as demonstrated by: a. Left ventricular ejection fraction greater than 40%. b. Pulmonary function test (PFT) demonstrating a diffusion capacity of least 40% predicted. c. Estimated serum creatinine clearance >/=60 ml/min (using the Cockcroft-Gault formula: creatinine clearance = [(140-age)*kg/(72*serum creatinine)] * 0.85 if female) and/or serum creatinine
  6. All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of the Revlimid REMS program.
  7. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program.
  8. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.
  9. Patients must have a CB unit available which is matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens.
  10. Availability of autologous peripheral blood stem cell graft, containing at least 6.0 x 10^6 CD34+ cells/kg, except those with relapsed disease within 18 months of prior ASCT, who should have at least 2.5 x 10^6 CD34+ cells/kg available.
  11. Patient or legally authorized representative able to sign informed consent.

Exclusion Criteria:

  1. Patients receiving any other investigational agents.
  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan.
  3. Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
  4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, uncontrolled hypertension (systolic >160, diastolic >100 despite antihypertensive therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  5. HIV-positive patients are excluded due to increased risk of lethal infections when treated with myeloablative chemotherapy.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Texas

Resources

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