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Multiple MyelomaPhase 2NCT02969837

Study of Initial Treatment With Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in Multiple Myeloma

A Phase 2 study testing Elotuzumab, Carfilzomib and Lenalidomide in people with Multiple Myeloma, run by University of Chicago at 3 sites 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 study was a multi-center, open-label, single-arm, Phase 2 study where newly diagnosed Multiple Myeloma requiring systemic chemotherapy will be eligible for enrollment. A total of 46 subjects were enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Elotuzumab, Carfilzomib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
3 sitesUnited States
Study dates
10 Jul 2017to 1 Dec 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study. No enrollment waivers will be granted.
  • Newly diagnosed, previously untreated myeloma requiring systemic chemotherapy
  • Prior treatment of hypercalcemia or spinal cord compression or active and/or aggressively progressing myeloma with corticosteroids and/or lenalidomide and/or bortezomib/PI-based regimens does not disqualify the subject (the corticosteroid treatment dose should not exceed the equivalent of 160 mg of dexamethasone in a 4 week period or not more than 1 cycle of lenalidomide and/or PI-based therapy)
  • Both transplant and non-transplant candidates are eligible.
  • Diagnosis of symptomatic multiple myeloma as per current IMWG uniform criteria prior to initial treatment
  • Monoclonal plasma cells in the BM 10% or presence of a biopsy-proven plasmacytoma
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  • Measurable disease, prior to initial treatment as indicated by one or more of the following:
  • Serum M-protein ≥ 1 g/dL
  • Urine M-protein ≥ 200 mg/24 hours
  • If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable (≥ 1 g/dL)
  • Involved serum free light chains ≥ 10 mg/dL provided that free light chain ratio is abnormal
  • Screening laboratory values must meet the following criteria and should be obtained within 21 days prior to enrollment WBC ≥ 2000/µL Platelets ≥ 75 x103/µL ANC >1000/µL Hemoglobin > 8.0 g/dL Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 50 mL/min
  • Use the Cockcroft-Gault formula below):
  • o Female CrCl = (140 - age in years) x weight in kg x 0.85
  • 72 x serum creatinine in mg/dL
  • o Male CrCl = (140 - age in years) x weight in kg x 1.00
  • 72 x serum creatinine in mg/dL
  • Alternatively to Cockcroft-Gault formula of CrCl, 24hr urine CrCl can be used AST/ALT ≤ 3 x ULN Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) or ≤ 2 x ULN if lenalidomide is being prescribed.
  • Males and females ≥ 18 years of age
  • ECOG performance status of 0-1
  • Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide. The first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for Cycle 1 (prescriptions must be filled within 7 days).
  • FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
  • Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
  • All study participants in the US must be consented to and registered into the mandatory Revlimid REMS program and be willing and able to comply with the requirements of Revlimid REMS.
  • Voluntary written informed consent

Who cannot join

  • Subjects meeting any of the following exclusion criteria are not eligible to enroll in this study. No enrollment waivers will be granted.
  • Non-secretory or hyposecretory multiple myeloma, prior to initial treatment defined as <1.0 g/dL M-protein in serum, <200 mg/24 hr urine M-protein, and no measurable disease as per IMWG by Freelite.
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Geriatric assessment score of ≥2 as defined by Palumbo et al.
  • Known or suspected Amyloidosis
  • Plasma cell leukemia
Show all 32Show fewer
  • Within 4 weeks since any plasmapheresis
  • Within 3 weeks of any corticosteroids except per inclusion criteria #2
  • Waldenström's macroglobulinemia or IgM myeloma
  • Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is greater
  • Subjects not able to tolerate elotuzumab, lenalidomide, carfilzomib, or dexamethasone
  • Peripheral neuropathy ≥ Grade 2 at screening
  • Prior CVA with persistent neurological deficit
  • Diarrhea > Grade 1 in the absence of antidiarrheals
  • CNS involvement
  • Corrected calcium ≥ 11.5 mg/dL within 2 weeks of randomization
  • Pregnant or lactating females
  • Radiotherapy within 14 days before randomization. Seven days may be considered if to single area
  • Major surgery within 3 weeks prior to first dose
  • Subject has clinically significant cardiac disease, including:
  • myocardial infarction within 1 year before Cycle 1 Day 1, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV
  • uncontrolled cardiac arrhythmia (NCI CTCAE Version 4 Grade 2:2) or clinically significant ECG abnormalities
  • screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec
  • Uncontrolled HTN 14 days prior to enrollment
  • Prior or concurrent deep vein thrombosis or pulmonary embolism
  • Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead ECG during screening
  • Uncontrolled hypertension (defined as average systolic blood pressure ≥140 or average diastolic blood pressure ≥90, with blood pressure measured ≥3 times in the two weeks prior to enrollment ) or diabetes
  • Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
  • Active infection
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects who are seropositive because of hepatitis B virus vaccine are eligible.
  • Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
  • Any clinically significant medical disease or condition that, in the Treating Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • University of Chicago

    Chicago, Illinois, 60637

  • NorthShore University Health System

    Evanston, Illinois, 60201

Other trials in United States

About this study

Official title: Open-label, Single-arm, Phase 2 Study of Initial Treatment With Elotuzumab, Carfilzomib (Kyprolis), Lenalidomide (Revlimid) and Low Dose Dexamethasone (E-KRd) in Newly Diagnosed, Multiple Myeloma Requiring Systemic Chemotherapy

This study was a multi-center, open-label, single-arm, Phase 2 study where newly diagnosed Multiple Myeloma requiring systemic chemotherapy will be eligible for enrollment. A total of 46 subjects were enrolled. The primary end point was the rate of stringent complete response (sCR) and/or MRD-negativity (10-5) after C8 Elo-KRd. Secondary end points included safety, rate of response, MRD status, PFS, and overall survival (OS).

Read the detailed description

Primary Objective

  • The primary efficacy endpoint will be the rate of sCR and/or the rate of negative MRD by next generation gene sequencing (NGS) by clonoSIGHT (Adaptive Biotechnologies) at the end of 8 cycles among non-transplant candidates and transplant candidates who agreed to defer transplant

Secondary Objectives

  • To evaluate the safety and tolerability of elotuzumab in combination with KRd, when administered to subjects with newly diagnosed multiple myeloma.
  • To determine the rate of MRD by next generation gene sequencing (NGS) by clonoSIGHT (Adaptive Biotechnologies) and by multi-color flow cytometry (MFC) at the end of Cycle 4, 8,and 12 for all subjects, and end of C18 (for subjects who are MRD+ at the end of C8 but MRD- at the end of C12 only), 24 months after C1D1, and yearly after that.
  • To estimate time to event, including duration of response (DOR), progression-free survival (PFS), time to progression (TTP), and overall survival (OS).

Exploratory Objectives

  • GEP, proteomics, and gene sequencing to evaluate the correlation between treatment outcome and pre-treatment subject profile.
  • Immunologic correlative studies including FcγRIIIa V genotype.
Being tested
Elotuzumab, Carfilzomib, Lenalidomide, Dexamethasone
Keywords
Multiple Myeloma, Elotuzumab, Carfilzomib (Kyprolis), Lenalidomide (Revlimid), Dexamethasone (E-KRd)
Medical subject headings
Multiple Myeloma

What participants receive

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

  • ElotuzumabDrug

    Also called Empliciti

    Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15

  • CarfilzomibDrug

    Also called Kryprolis

    Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond

  • LenalidomideDrug

    Also called Revlimid

    Lenalidomide will be given on days 1-21 for all cycles.

  • DexamethasoneDrug

    Dexamethasone will be given as follows:

    Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22

Study groups in NCT02969837
Study groupRoleWhat they receive
Elo-KRd regimenExperimentalSubjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression.
Receives: Drug: Elotuzumab; Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

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

  1. Number of Participants With Stringent Complete Response (sCR)

    Response will be determined according to the International Myeloma Working Group (IMWG) response criteria for multiple myeloma.

    sCR is defined as CR plus :

    • normal FLC ratio and
    • absence of clonal cells in bone marrow by immunohistochemistry or 2 - 4 color flow cytometry

    CR is defined as below :

    • Negative immunofixation on the serum and urine and
    • disappearance of any soft tissue plasmacytomas and
    • < 5% plasma cells in bone marrow.
    • In subjects with only FLC disease, a normal FLC ratio of 0.26-1.65 is required.

    Measured: Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)

  2. Number of Participants With MRD-negativity (10^-5) After C8 Elo-KRd

    Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycle 8.

    The flow cytometry analysis procedure used to determine MRD is performed on a NAVIOS FLOW CYTOMETER SYSTEM manufactured by BECKMAN COULTER, INC., using a laboratory developed assay.

    The Premarket Notification 510(k) (Number K130373) for the device can be found using the following link.

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130373.

    Measured: Landmark evaluations were performed after cycle 8

  3. The Number of Participants With Stringent Complete Response (sCR) and/or MRD Negative (10^-5) by NGS

    Response will be determined according to the International Myeloma Working Group (IMWG) response criteria for multiple myeloma.

    sCR is defined as CR plus :

    • normal FLC ratio and
    • absence of clonal cells in bone marrow by immunohistochemistry or 2 - 4 color flow cytometry

    CR is defined as below :

    • Negative immunofixation on the serum and urine and
    • disappearance of any soft tissue plasmacytomas and
    • < 5% plasma cells in bone marrow.
    • In subjects with only FLC disease, a normal FLC ratio of 0.26-1.65 is required.

    Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 4,8,12,18 and 24.

    The flow cytometry analysis procedure used to determine MRD is performed on a NAVIOS FLOW CYTOMETER SYSTEM manufactured by BECKMAN COULTER, INC., using a laboratory developed assay.

    Measured: Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)

Secondary outcomes (4)

  1. Number of Participants With Adverse Events of Elotuzumab in Combination With KRd

    AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

    Measured: AEs were recorded from the day of signed consent through 30 days after the last does of Elo-KRd or initiation of new therapy, an average of 2 years.

  2. Duration of Response

    These events will be analyzed at differing points of time based on the individual subjects disease progression. It will be measured by the number of cycles of therapy.

    Measured: Up to two years

  3. Median Progression Free Survival

    Progression free survival (PFS) was assessed based on time to disease progression or death (whichever occurred first) from the start of treatment.

    Measured: up to two years

  4. Median Overall Survival

    Overall survival (OS) was assessed based on time to disease progression or death (whichever occurred first) from the start of treatment.

    Measured: up to two years

Timeline

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

  1. First posted21 Nov 2016 (estimated)
  2. Study start10 Jul 2017
  3. Primary completion11 Oct 2021
  4. Study completion1 Dec 2025

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
Model description
All participants will receive E-KRd regimen (elotuzumab, carfilzomib, lenalidomide, and dexamethasone) for up to 12 Cycles. After Cycle 12, participants that are MRD negative will move to E-Rd (elotuzumab, carfilzomib, lenalidomide, and dexamethasone) maintenance regimen and continue until disease progression. Participants that are MRD positive will continue to receive E-KRd regimen for an additional 6 cycles followed by E-Rd maintenance regimen and continue until disease progression
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02969837
Sponsor's protocol ID
IRB16-1138
Status last verified
Dec 2025
First submitted
14 Nov 2016
Last updated
16 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Derman BA, Kansagra A, Zonder J, Stefka AT, Grinblatt DL, Anderson LD Jr, Gurbuxani S, Narula S, Rayani S, Major A, Kin A, Jiang K, Karrison T, Jasielec J, Jakubowiak AJ. Elotuzumab and Weekly Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Without Transplant Intent: A Phase 2 Measurable Residual Disease-Adapted Study. JAMA Oncol. 2022 Sep 1;8(9):1278-1286. doi: 10.1001/jamaoncol.2022.2424.

    PubMed 35862034

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elotuzumab, Carfilzomib and Lenalidomide in people with Multiple Myeloma, run by University of Chicago at 3 sites 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 25 inclusion and 32 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 10 Sep 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 Stringent Complete Response (sCR) (time frame: Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)). The study lists 3 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 NCT02969837, which also lists 1 linked publication.

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 16 Jan 2026.

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