NCT02969837 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-01-16

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Stringent Complete Response (sCR)

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Duration of Response

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outcome · POSTED

Median Progression Free Survival

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outcome · POSTED

Median Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study. No enrollment waivers will be granted. 1. Newly diagnosed, previously untreated myeloma requiring systemic chemotherapy a. 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) 2. Both transplant and non-transplant candidates are eligible. 3. Diagnosis of symptomatic multiple myeloma as per current IMWG uniform criteria prior to initial treatment 4. Monoclonal plasma cells in the BM 10% or presence of a biopsy-proven plasmacytoma 5. Measurable disease, prior to initial treatment as indicated by one or more of the following: 1. Serum M-protein ≥ 1 g/dL 2. Urine M-protein ≥ 200 mg/24 hours 3. If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable (≥ 1 g/dL) 4. Involved serum free light chains ≥ 10 mg/dL provided that free light chain ratio is abnormal 6. 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 1. 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 2. 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. 7. Males and females ≥ 18 years of age 8. ECOG performance status of 0-1 9. 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). 10. 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. 11. 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. 12. 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. 13. Voluntary written informed consent Exclusion Criteria: * Subjects meeting any of the following exclusion criteria are not eligible to enroll in this study. No enrollment waivers will be granted. 1. 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. 2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 3. Geriatric assessment score of ≥2 as defined by Palumbo et al. 4. Known or suspected Amyloidosis 5. Plasma cell leukemia 6. Within 4 weeks since any plasmapheresis 7. Within 3 weeks of any corticosteroids except per inclusion criteria #2 8. Waldenström's macroglobulinemia or IgM myeloma 9. 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 10. Subjects not able to tolerate elotuzumab, lenalidomide, carfilzomib, or dexamethasone 11. Peripheral neuropathy ≥ Grade 2 at screening 12. Prior CVA with persistent neurological deficit 13. Diarrhea \> Grade 1 in the absence of antidiarrheals 14. CNS involvement 15. Corrected calcium ≥ 11.5 mg/dL within 2 weeks of randomization 16. Pregnant or lactating females 17. Radiotherapy within 14 days before randomization. Seven days may be considered if to single area 18. Major surgery within 3 weeks prior to first dose 19. 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 20. Uncontrolled HTN 14 days prior to enrollment 21. Prior or concurrent deep vein thrombosis or pulmonary embolism 22. Rate-corrected QT interval of electrocardiograph (QTc) \> 470 msec on a 12-lead ECG during screening 23. 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 24. Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose 25. Active infection 26. 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. 27. 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 28. 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects 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.
intervention Names
Drug: Elotuzumab
Drug: Carfilzomib
Drug: Lenalidomide
Drug: Dexamethasone
label
Elo-KRd regimen
type
EXPERIMENTAL

interventions

arm Group Labels
Elo-KRd regimen
description
Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15
name
Elotuzumab
other Names
Empliciti
type
DRUG
arm Group Labels
Elo-KRd regimen
description
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
name
Carfilzomib
other Names
Kryprolis
type
DRUG
arm Group Labels
Elo-KRd regimen
description
Lenalidomide will be given on days 1-21 for all cycles.
name
Lenalidomide
other Names
Revlimid
type
DRUG
arm Group Labels
Elo-KRd regimen
description
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
name
Dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

intervention 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 Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 46
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
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)
description
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.
measure
Number of Participants With MRD-negativity (10^-5) After C8 Elo-KRd
time Frame
Landmark evaluations were performed after cycle 8
description
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.
measure
The Number of Participants With Stringent Complete Response (sCR) and/or MRD Negative (10^-5) by NGS
time Frame
Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)

secondary Outcomes

description
AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
measure
Number of Participants With Adverse Events of Elotuzumab in Combination With KRd
time Frame
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.
description
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.
measure
Duration of Response
time Frame
Up to two years
description
Progression free survival (PFS) was assessed based on time to disease progression or death (whichever occurred first) from the start of treatment.
measure
Median Progression Free Survival
time Frame
up to two years
description
Overall survival (OS) was assessed based on time to disease progression or death (whichever occurred first) from the start of treatment.
measure
Median Overall Survival
time Frame
up to two years

Full study description

brief 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. 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).
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.

Source references

references

citation
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.
pmid
35862034
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice