Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma
CompletedPhase 2Results postedLast updated 9 May 2025
What this trial tests
Phase 2 trial testing Autologous Hematopoietic Stem Cell Transplantation in Plasma Cell Leukemia in 72 participants. Completed in 25 June 2024.
Adults 18 to 75, any sex, with Plasma Cell Leukemia or Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose Limiting ToxicitiesPrimary· Within 30 days post-transplant
Dose limiting toxicity is defined as number of participants experienced:
* grade 4 NK infusion related toxicity,
* failure to engraft by D+28 or delayed engraftment,
* grades 3-5 allergic reactions related to study cell infusion,
* grade 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy or due to preparative chemotherapy and occurring within 30 days (+3 days if necessary) post-transplant,
* grades 3-4 acute GVHD occurring within 45 days post-transplant,
* treatment-related d
grade 4 NK infusion related toxicity
Group
Value
95% CI
P1_C1_5x10^6
0
P1_C2_1x10^7
0
P1_C3_5x10^7
0
P1_C4_1X10^8
0
P2_1x10^8+Elotuzumab
0
failure to engraft by D+28 or delayed engraftment
Group
Value
95% CI
P1_C1_5x10^6
0
P1_C2_1x10^7
0
P1_C3_5x10^7
0
P1_C4_1X10^8
1
P2_1x10^8+Elotuzumab
0
· grades 3-5 allergic reactions related to study cell infusion
Group
Value
95% CI
P1_C1_5x10^6
0
P1_C2_1x10^7
0
P1_C3_5x10^7
0
P1_C4_1X10^8
0
P2_1x10^8+Elotuzumab
0
grade 3-5 organ toxicity
Group
Value
95% CI
P1_C1_5x10^6
1
P1_C2_1x10^7
0
P1_C3_5x10^7
0
P1_C4_1X10^8
13
P2_1x10^8+Elotuzumab
11
grades 3-4 acute GVHD occurring within 45 days post-transplant
Group
Value
95% CI
P1_C1_5x10^6
0
P1_C2_1x10^7
0
P1_C3_5x10^7
0
P1_C4_1X10^8
0
P2_1x10^8+Elotuzumab
0
treatment-related death within 8 weeks of the study cell infusion
Group
Value
95% CI
P1_C1_5x10^6
0
P1_C2_1x10^7
0
P1_C3_5x10^7
0
P1_C4_1X10^8
0
P2_1x10^8+Elotuzumab
0
Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR)Primary· At 3 months post-transplant
Complete response (CR) (all of the following):
1. Negative immunofixation in serum and urine.
2. \< 5% plasma cells in the bone marrow.
3. Disappearance of any soft tissue plasmacytomas.
Very good partial response (VGPR) (one of the following):
1. Serum and urine M protein detectable by immunofixation but not by electrophoresis.
2. 90% or greater reduction in serum M protein plus urine M protein level \<100 mg per 4h.
VGPR
Group
Value
95% CI
P1_C1_5x10^6
1
P1_C2_1x10^7
0
P1_C3_5x10^7
1
P1_C4_1X10^8
4
P2_1x10^8+Elotuzumab
5
CR
Group
Value
95% CI
P1_C1_5x10^6
1
P1_C2_1x10^7
3
P1_C3_5x10^7
2
P1_C4_1X10^8
17
P2_1x10^8+Elotuzumab
22
Progression-free Survival (PFS)Secondary· Up to 12 months
Number of participants that are alive and disease free one year post transplant
Group
Value
95% CI
P1_C1_5x10^6
2
P1_C2_1x10^7
2
P1_C3_5x10^7
4
P1_C4_1X10^8
28
P2_1x10^8+Elotuzumab
28
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 9 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01729091.