NCT02969837

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

Completed Phase 2 Results posted Last updated 16 January 2026

What this trial tests

Phase 2 trial testing Elotuzumab in Multiple Myeloma in 46 participants. Completed in 1 December 2025.

Timeline

10 July 2017

Primary endpoint
11 October 2021

1 December 2025

Quick facts

Lead sponsor	University of Chicago
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	10 July 2017
Primary completion	11 October 2021
Estimated completion	1 December 2025
Sites	3 locations across United States

Drugs / interventions tested

• Elotuzumab (elotuzumab) — full drug profile →
• Carfilzomib (carfilzomib) — full drug profile →
• Lenalidomide — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

University of Chicago

Who can join

18 and older, any sex, with Multiple 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 Stringent Complete Response (sCR) Primary · Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)

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.

Group	Value	95% CI
Elo-KRd Regimen	17

Number of Participants With MRD-negativity (10^-5) After C8 Elo-KRd Primary · Landmark evaluations were performed after cycle 8

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.

Group	Value	95% CI
Elo-KRd Regimen	26

The Number of Participants With Stringent Complete Response (sCR) and/or MRD Negative (10^-5) by NGS Primary · Landmark evaluations were performed after cycles 4, 8, 12, 18 and 24 (that is, 4, 8, 12, 18 and 24 months)

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 Gene

Group	Value	95% CI
Elo-KRd Regimen	26

Number of Participants With Adverse Events of Elotuzumab in Combination With KRd Secondary · 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.

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

Anemia

Group	Value	95% CI
Elo-KRd Regimen	11

Neutropenia

Group	Value	95% CI
Elo-KRd Regimen	9

Thrombocytopenia

Group	Value	95% CI
Elo-KRd Regimen	8

Lymphopenia

Group	Value	95% CI
Elo-KRd Regimen	4

Fatigue

Group	Value	95% CI
Elo-KRd Regimen	33

Infection-Upper respiratory

Group	Value	95% CI
Elo-KRd Regimen	19

Infection-Non-pulmonary

Group	Value	95% CI
Elo-KRd Regimen	22

Infection-Lung

Group	Value	95% CI
Elo-KRd Regimen	7

Duration of Response Secondary · Up to two years

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.

Group	Value	95% CI
Elo-KRd Regimen	23	2 – 39

Median Progression Free Survival Secondary · up to two years

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

Group	Value	95% CI
Elo-KRd Regimen	NA	NA – NA

Median Overall Survival Secondary · up to two years

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

Group	Value	95% CI
Elo-KRd Regimen	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Elo-KRd Regimen

Serious: 18/46 (39%)

Deaths: 8/46

Serious adverse events (18 terms)

Reaction	System	Elo-KRd Regimen
Lung infection	Infections and infestations	—
Febrile neutropenia	Blood and lymphatic system disorders	—
Fever	General disorders	—
Acute kidney injury	Renal and urinary disorders	—
Atrial fibrillation	Cardiac disorders	—
Bronchial infection	Infections and infestations	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Ejection fraction decreased	Investigations	—
Hyperglycemia	Metabolism and nutrition disorders	—
Hypotension	Vascular disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Infections and infestations - Other	Infections and infestations	—
Myocardial infraction	Cardiac disorders	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	—
Renal and urinary disorders - Other	Renal and urinary disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Thromboembolic event	Vascular disorders	—

Other adverse events (49 terms — click to expand)

Reaction	System	Elo-KRd Regimen
Fatigue	General disorders	—
Diarrhea	Gastrointestinal disorders	—
Edema limbs	General disorders	—
Peripheral sensory neuropathy	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Insomnia	Psychiatric disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
White blood cell decreased	Investigations	—
Alanine aminotransferase increased	Investigations	—
Fever	General disorders	—
Anemia	Blood and lymphatic system disorders	—
Dizziness	Nervous system disorders	—
Hypertension	Vascular disorders	—
Localized edema	General disorders	—
Musculoskeletal and connective tissue disorder - Other	Musculoskeletal and connective tissue disorders	—
Platelet count decreased	Investigations	—
Upper respiratory infection	Infections and infestations	—
Constipation	Gastrointestinal disorders	—
Neutrophil count decreased	Investigations	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Skin and subcutaneous tissue disorders- Other	Skin and subcutaneous tissue disorders	—
Weight gain	Investigations	—
Hypokalemia	Metabolism and nutrition disorders	—
Aspartate aminotransferase increased	Investigations	—
Blurred vision	Eye disorders	—
Dyspepsia	Gastrointestinal disorders	—
Infusion related reaction	General disorders	—
Paresthesia	Nervous system disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Thromboembolic event	Vascular disorders	—
Tremor	Nervous system disorders	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—
Agitation	Psychiatric disorders	—
Atrial fibrillation	Cardiac disorders	—
Lymphocyte count decreased	Investigations	—
Vomiting	Gastrointestinal disorders	—
Cardiac disorders - Other	Cardiac disorders	—
Chills	General disorders	—

Most-reported serious reactions: Lung infection, Febrile neutropenia, Fever, Acute kidney injury, Atrial fibrillation, Bronchial infection, Dyspnea, Ejection fraction decreased.

Data from ClinicalTrials.gov NCT02969837 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone as maintenance therapy after autologous stem-cell transplantation in patients with multiple myeloma (ATLAS): interim analysis of a randomised, open-label, phase 3 trial.
   Dytfeld D, Wróbel T, Jamroziak K, Kubicki T, et al · · 2023 · cited 60× · PMID 36642080 · DOI 10.1016/s1470-2045(22)00738-0
2. Minimal Residual Disease in Multiple Myeloma: Current Landscape and Future Applications With Immunotherapeutic Approaches.
   Kostopoulos IV, Ntanasis-Stathopoulos I, Gavriatopoulou M, Tsitsilonis OE, et al · · 2020 · cited 42× · PMID 32537439 · DOI 10.3389/fonc.2020.00860
3. Deregulation of Adaptive T Cell Immunity in Multiple Myeloma: Insights Into Mechanisms and Therapeutic Opportunities.
   Leblay N, Maity R, Hasan F, Neri P. · · 2020 · cited 36× · PMID 32432039 · DOI 10.3389/fonc.2020.00636
4. Measurable residual disease in multiple myeloma: ready for clinical practice?
   Burgos L, Puig N, Cedena MT, Mateos MV, et al · · 2020 · cited 32× · PMID 32571377 · DOI 10.1186/s13045-020-00911-4
5. Monoclonal Antibodies and Antibody Drug Conjugates in Multiple Myeloma.
   Radocha J, van de Donk NWCJ, Weisel K. · · 2021 · cited 30× · PMID 33805481 · DOI 10.3390/cancers13071571
6. Therapeutic Monoclonal Antibodies and Antibody Products: Current Practices and Development in Multiple Myeloma.
   Bonello F, Mina R, Boccadoro M, Gay F. · · 2019 · cited 30× · PMID 31861548 · DOI 10.3390/cancers12010015
7. The role of high-dose melphalan with autologous stem-cell transplant in multiple myeloma: is it time for a paradigm shift?
   Kazandjian D, Mo CC, Landgren O, Richardson PG. · · 2020 · cited 25× · PMID 32501533 · DOI 10.1111/bjh.16764
8. 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.
   Derman BA, Kansagra A, Zonder J, Stefka AT, et al · · 2022 · cited 24× · PMID 35862034 · DOI 10.1001/jamaoncol.2022.2424