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Powerful cocktail shows promise against bone marrow cancer

NCT ID NCT02969837

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a combination of four drugs—elotuzumab, carfilzomib, lenalidomide, and dexamethasone—in 46 people newly diagnosed with multiple myeloma. The goal was to see how many patients achieved a very deep response (stringent complete response or minimal residual disease negativity). The study found that the combination led to high response rates, suggesting it could be a strong initial treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elotuzumab, carfilzomib, lenalidomide, dexamethasone
What this could lead to
If successful, this combination could become a powerful first-line treatment for multiple myeloma, potentially leading to deeper remissions and longer survival.
What could go wrong
This is a small, single-arm phase 2 study with no comparison group, so results may not hold up in larger trials. Side effects from the drug combination can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

46 people

The number who actually took part.

Started

Jul 2017

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

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