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Plasma Cell LeukemiaPhase 2NCT01729091

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

A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Elotuzumab and Laboratory Biomarker Analysis in people with Plasma Cell Leukemia and Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plasma Cell Leukemia, Plasma Cell Myeloma
What is being tested?
Autologous Hematopoietic Stem Cell Transplantation, Elotuzumab and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
10 Jun 2013to 25 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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 =< 1.6 mg/dL
  • Serum glutamate pyruvate transaminase (SGPT) less than 3 x upper limit of normal
  • Total bilirubin less than 2 x upper limit of normal
  • All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the Revlimid REMS program
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
  • 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
  • Patients must have a cord blood (CB) unit available which is matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens
  • Patient or legally authorized representative able to sign informed consent

Who cannot join

  • Patients receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan
  • Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide
  • 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
  • Human immunodeficiency virus (HIV)-positive patients are excluded due to increased risk of lethal infections when treated with myeloablative chemotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Autologous Hematopoietic Stem Cell Transplantation, Elotuzumab, Laboratory Biomarker Analysis, Lenalidomide, Melphalan
Medical subject headings
Leukemia, Plasma Cell, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called Autologous Hematopoietic Cell Transplantation, autologous stem cell transplantation

    Undergo autologous stem cell transplant

  • ElotuzumabBiological

    Also called BMS-901608, Empliciti, HuLuc-63, HuLuc63

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

  • MelphalanDrug

    Also called Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard

    Given IV

  • Natural Killer Cell TherapyBiological

    Given IV

  • Umbilical Cord Blood-Derived Lymphocyte TherapyBiological

    Given IV

Study groups in NCT01729091
Study groupRoleWhat they receive
Treatment (chemotherapy, UCB-derived NK cells, transplant)ExperimentalPatients receive elotuzumab IV over 2-5 hours on day -15 and -8, lenalidomide PO 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.
Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Biological: Elotuzumab; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide; Drug: Melphalan; Biological: Natural Killer Cell Therapy; Biological: Umbilical Cord Blood-Derived Lymphocyte Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities

    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 death within 8 weeks of the study cell infusion.

    Measured: Within 30 days post-transplant

  2. Number of Participants That Achieved Very Good Response (VGPR) + Complete Response (CR)

    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.

    Measured: At 3 months post-transplant

Secondary outcomes (1)

  1. Progression-free Survival (PFS)

    Number of participants that are alive and disease free one year post transplant

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2012 (estimated)
  2. Study start10 Jun 2013
  3. Primary completion25 Jun 2024
  4. Study completion25 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01729091
Sponsor's protocol ID
2011-0379
Other IDs
NCI-2014-01096, RV-MM-PI-0691, NCI-2014-00541, 2011-0379
Status last verified
May 2025
First submitted
9 Nov 2012
Last updated
9 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Elotuzumab and Laboratory Biomarker Analysis in people with Plasma Cell Leukemia and Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (time frame: Within 30 days post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01729091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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