Phase 2
Completed N=72
Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT01729091 ↗Enrolled (actual)
72
Serious AEs
2.8%
Results posted
May 2025
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR) |
1; 0; 1; 4; 5; 1 | — |
| SECONDARY Progression-free Survival (PFS) |
2; 2; 4; 28; 28 | — |
Eligibility Criteria
Inclusion Criteria
- 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:
- Fluorescence in situ hybridization showing t(4: 14), t(14:16), t(14:20), gain (amp) 1q; deletion (Del) 17/17p [or tp53 gene mutation/deletion by next generation sequencing (NGS), or by conventional cytogenetics];
- Deletion 13 by conventional cytogenetic analysis;
- High risk signatures as determined by the GEP-70 or EMC-92 gene expression profiles;
- Relapsed disease within 18 months of prior autologous stem cell transplant (ASCT)
- Patients with plasma cell leukemia who are transplant candidates
- Performance score of at least 70% by Karnofsky or 0 to 2 Eastern Cooperative Oncology Group (ECOG)
- Left ventricular ejection fraction greater than 40%
- Pulmonary function test (PFT) demonstrating a diffusion capacity of least 40% predicted
- Estimated serum creatinine clearance >= 60 ml/min (using the Cockcroft-Gault formula and/or serum creatinine = 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
- Human immunodeficiency virus (HIV)-positive patients are excluded due to increased risk of lethal infections when treated with myeloablative chemotherapy
Data sourced from ClinicalTrials.gov (NCT01729091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.