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Proteasome Inhibitor

Elotuzumab + Triple Therapy for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Saad Usmani

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have POEMS syndrome

Patients must not have active involvement of the central nervous system (CNS) with MM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years post registration

Awards & highlights

Study Summary

This trial is studying elotuzumab in combination with lenalidomide, bortezomib, and dexamethasone to treat patients with newly diagnosed multiple myeloma.

Who is the study for?

This trial is for newly diagnosed high-risk multiple myeloma patients without prior malignancies, except certain treated cases. They must not have POEMS syndrome or CNS involvement by MM, and should meet specific blood count and organ function criteria. Women of childbearing age need a negative pregnancy test and agreed birth control measures. Participants must consent to specimen banking for research.Check my eligibility

What is being tested?

The study tests if adding Elotuzumab to the combination of Lenalidomide, Bortezomib, and Dexamethasone improves treatment outcomes in high-risk multiple myeloma patients. It's a phase I/II trial that also aims to determine the best dose with acceptable side effects.See study design

What are the potential side effects?

Potential side effects include reactions related to immune response, nerve damage (neuropathy), fatigue, digestive issues like constipation or diarrhea, blood clots, risk of infection due to low white blood cell counts, and possible impact on liver or kidney functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have POEMS syndrome.

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My multiple myeloma has not spread to my brain or spinal cord.

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I do not have any serious illnesses, including heart problems, high blood pressure, or diabetes.

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I meet the specific requirements for past chemotherapy and radiotherapy.

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My blood, liver, and kidney tests meet the required levels.

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I am able to have children, not pregnant, and agree to use birth control.

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I have been recently diagnosed with active multiple myeloma.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone

Progression-free Survival

Secondary outcome measures

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Overall Survival

Response (Partial Response [PR] or Better) Rate

Side effects data

From 2022 Phase 3 trial • 170 Patients • NCT02726581

34%

Fatigue

31%

Upper respiratory tract infection

31%

Neutropenia

29%

Anaemia

24%

Pneumonia

24%

Diarrhoea

21%

Oedema peripheral

21%

Back pain

21%

Constipation

21%

Dyspnoea

17%

Nasopharyngitis

17%

Asthenia

17%

Cough

16%

Insomnia

16%

Nausea

16%

Thrombocytopenia

16%

Muscle spasms

14%

Dizziness

14%

Decreased appetite

14%

Hyperglycaemia

13%

Pyrexia

13%

Hypertension

11%

Rash

11%

Arthralgia

10%

Platelet count decreased

10%

White blood cell count decreased

10%

Headache

10%

Hypomagnesaemia

Lymphocyte count decreased

Pain

Vomiting

Neuropathy peripheral

Malignant neoplasm progression

Neutrophil count decreased

Hypokalaemia

Tremor

Confusional state

Respiratory tract infection

Bone pain

Urinary tract infection

Bronchitis

Abdominal pain

Abdominal distension

Dry mouth

Cataract

Paraesthesia

Wheezing

Chest pain

Chills

Non-cardiac chest pain

Hypophosphataemia

Muscular weakness

Musculoskeletal chest pain

Myalgia

Anxiety

Chronic kidney disease

Dysphonia

Nasal congestion

Pruritus

Blood creatinine increased

Acute kidney injury

Hyperuricaemia

Hyperkalaemia

Febrile neutropenia

Influenza

Fall

Hypercalcaemia

Pain in extremity

Epistaxis

Sepsis

Hypocalcaemia

Pulmonary embolism

Hypoaesthesia

Leukopenia

Humerus fracture

Plasma cell myeloma

Syncope

Respiratory failure

Sinusitis

Alanine aminotransferase increased

Productive cough

Atrial fibrillation

Septic shock

Vision blurred

Cardiac failure

Aspartate aminotransferase increased

Hyponatraemia

Rhinovirus infection

Renal failure

Skin laceration

Cerebral thrombosis

Urinary retention

Myocardial infarction

Hand-foot-and-mouth disease

Pulmonary sepsis

Peripheral sensory neuropathy

Dehydration

Alopecia

Cytomegalovirus viraemia

Diverticulitis

Erysipelas

Escherichia urinary tract infection

Gastroenteritis

Pneumonia fungal

Pneumonia legionella

Atrioventricular block complete

Cardiac arrest

Cardiac failure acute

Sinus node dysfunction

Vertigo

Condition aggravated

Respiratory syncytial virus infection

Hypersensitivity

Bacteraemia

Cellulitis

Wound infection

Femur fracture

Lower limb fracture

Lung cancer metastatic

Encephalopathy

Haemorrhage intracranial

Renal impairment

Acute respiratory failure

Dyspnoea exertional

Deep vein thrombosis

Lymphopenia

Pancytopenia

Sinus bradycardia

Hyperthyroidism

Candida infection

Neck pain

Atelectasis

Hypoxia

Hypotension

Infection

Plasmacytoma

Refractory cytopenia with unilineage dysplasia

Hypovolaemic shock

Impaired healing

Post procedural complication

Arthritis

100%

80%

60%

40%

20%

Study treatment Arm

Arm B: Pd

Arm C: NE-Pd

Arm B: NE-Pd Crossover

Arm A: N-Pd

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (bortezomib, lenalidomide, dexamethasone, elotuzumab)Experimental Treatment5 Interventions

INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (bortezomib, lenalidomide, dexamethasone)Active Control4 Interventions

INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Bortezomib

2005

Completed Phase 2

~1140

Elotuzumab

2016

Completed Phase 3

~800

Lenalidomide

2005

Completed Phase 3

~1480

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,669 Total Patients Enrolled

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

265,028 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,011 Total Patients Enrolled

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01668719 — Phase 1 & 2

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01668719 — Phase 1 & 2

Monoclonal Gammopathy Research Study Groups: Arm II (bortezomib, lenalidomide, dexamethasone, elotuzumab), Arm I (bortezomib, lenalidomide, dexamethasone)

Monoclonal Gammopathy Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT01668719 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has research involving Elotuzumab been conducted previously?

"The exploration of elotuzumab began in 2002, with 2150 studies having been finished since then. Currently 737 trials are actively recruiting participants, many at the Pekin site located in Illinois."

Answered by AI

What aims are being pursued with this research endeavor?

"The primary success metric for this clinical trial is Progression Free Survival (PFS). Secondary outcomes include Response rate, Overall survival, and the Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs. To calculate these measures DLTs will be assessed over a 21 day period in Cycle 1, with Fisher's Exact Test used to compare arms between each other; long-rank tests and Kaplan-Meier employed for overall survival estimations; CTCAE Version 4.0 utilized to record AEs potentially linked to study drugs."

Answered by AI

What is the predominant application of Elotuzumab?

"Elotuzumab is a medication capable of managing ophthalmia, sympathetic and branch retinal vein occlusion as well as macular edema in those who have undergone at least two prior systemic chemotherapy regimens."

Answered by AI

How many participants are being accepted for this clinical research?

"This investigation is not currently recruiting. It was first posted on November 1st 2012 and last updated on May 6th 2022. For those looking for other trials, there are 807 relevant studies accepting enrolment related to multiple myeloma and 737 regarding Elotuzumab that are still open."

Answered by AI

Is enrollment open for this clinical test?

"According to clinicaltrials.gov, this pharmaceutical trial is presently not recruiting participants. Initially posted on November 1st 2012 and last updated on May 6th 2022, the study has yet to accept any new candidates. However, there are a plethora of other trials looking for volunteers at the moment with 1544 studies seeking applicants currently."

Answered by AI

What is the prevalence of this scientific experimentation within city limits?

"Across the country, there are 100 trial sites which includes Illinois CancerCare-Pekin in Pekin, Mercy Medical Center-Sioux City in Sioux City, and Cancer Therapy and Integrative Medicine in Las Vegas."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Bortezomib, Lenalidomide, and Dexamethasone with or Without Elotuzumab in Patients with Untreated, High-risk Multiple Myeloma (SWOG-1211): Primary Analysis of a Randomised, Phase 2 Trial

Usmani, Saad Z, Antje Hoering, Sikander Ailawadhi, Rachael Sexton, Brea Lipe, Sandi Fredette Hita, Jason Valent, et al.. 2021. “Bortezomib, Lenalidomide, and Dexamethasone with or Without Elotuzumab in Patients with Untreated, High-risk Multiple Myeloma (SWOG-1211): Primary Analysis of a Randomised, Phase 2 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(20)30354-9.

clinicaltrials.govStudy

S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma

2012. "S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01668719.

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