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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
Must not have
Patients who are HIV+ and do not meet specific additional criteria are not eligible for this study
Patients with non-secretory MM or known amyloidosis are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years post registration
Awards & highlights

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV+ and meet all required health criteria for the study.
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I do not have non-secretory multiple myeloma or amyloidosis.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone
Progression-free Survival
Secondary study objectives
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%
Decreased appetite
14%
Dizziness
14%
Hyperglycaemia
13%
Pyrexia
13%
Hypertension
11%
Rash
11%
Arthralgia
10%
Platelet count decreased
10%
White blood cell count decreased
10%
Headache
10%
Hypomagnesaemia
9%
Lymphocyte count decreased
9%
Vomiting
9%
Pain
9%
Neuropathy peripheral
9%
Malignant neoplasm progression
9%
Neutrophil count decreased
9%
Hypokalaemia
9%
Tremor
9%
Confusional state
9%
Respiratory tract infection
9%
Bone pain
7%
Bronchitis
7%
Urinary tract infection
7%
Abdominal pain
7%
Abdominal distension
7%
Dry mouth
6%
Cataract
6%
Paraesthesia
6%
Wheezing
6%
Chest pain
6%
Chills
6%
Non-cardiac chest pain
6%
Hypophosphataemia
6%
Muscular weakness
6%
Musculoskeletal chest pain
6%
Myalgia
6%
Anxiety
6%
Chronic kidney disease
6%
Dysphonia
6%
Nasal congestion
6%
Pruritus
6%
Blood creatinine increased
4%
Acute kidney injury
4%
Hyperkalaemia
4%
Hyperuricaemia
4%
Febrile neutropenia
4%
Influenza
4%
Fall
4%
Hypercalcaemia
4%
Pain in extremity
4%
Epistaxis
4%
Sepsis
4%
Hypocalcaemia
3%
Pulmonary embolism
3%
Hypoaesthesia
3%
Leukopenia
3%
Humerus fracture
3%
Plasma cell myeloma
3%
Syncope
3%
Respiratory failure
3%
Sinusitis
3%
Alanine aminotransferase increased
3%
Productive cough
3%
Atrial fibrillation
3%
Septic shock
3%
Vision blurred
3%
Cardiac failure
3%
Aspartate aminotransferase increased
3%
Hyponatraemia
1%
Myocardial infarction
1%
Pulmonary sepsis
1%
Hand-foot-and-mouth disease
1%
Rhinovirus infection
1%
Skin laceration
1%
Cerebral thrombosis
1%
Renal failure
1%
Dehydration
1%
Peripheral sensory neuropathy
1%
Urinary retention
1%
Alopecia
1%
Cytomegalovirus viraemia
1%
Diverticulitis
1%
Erysipelas
1%
Escherichia urinary tract infection
1%
Gastroenteritis
1%
Pneumonia fungal
1%
Pneumonia legionella
1%
Atrioventricular block complete
1%
Cardiac arrest
1%
Cardiac failure acute
1%
Sinus node dysfunction
1%
Vertigo
1%
Condition aggravated
1%
Respiratory syncytial virus infection
1%
Hypersensitivity
1%
Bacteraemia
1%
Cellulitis
1%
Wound infection
1%
Femur fracture
1%
Lower limb fracture
1%
Lung cancer metastatic
1%
Encephalopathy
1%
Haemorrhage intracranial
1%
Renal impairment
1%
Acute respiratory failure
1%
Dyspnoea exertional
1%
Deep vein thrombosis
1%
Lymphopenia
1%
Pancytopenia
1%
Sinus bradycardia
1%
Hyperthyroidism
1%
Candida infection
1%
Neck pain
1%
Atelectasis
1%
Hypoxia
1%
Hypotension
1%
Infection
1%
Plasmacytoma
1%
Refractory cytopenia with unilineage dysplasia
1%
Hypovolaemic shock
1%
Impaired healing
1%
Post procedural complication
1%
Arthritis
100%
80%
60%
40%
20%
0%
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
~2640
Bortezomib
2005
Completed Phase 3
~1410
Elotuzumab
2016
Completed Phase 3
~870
Lenalidomide
2005
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,045 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
264,932 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,858 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
~11 spots leftby Sep 2025
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