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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
No Placebo-Only Group
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 belowSelect...
I do not have POEMS syndrome.
Select...
My multiple myeloma has not spread to my brain or spinal cord.
Select...
I do not have any serious illnesses, including heart problems, high blood pressure, or diabetes.
Select...
I meet the specific requirements for past chemotherapy and radiotherapy.
Select...
My blood, liver, and kidney tests meet the required levels.
Select...
I am able to have children, not pregnant, and agree to use birth control.
Select...
I have been recently diagnosed with active multiple myeloma.
Select...
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:Select...
I am HIV+ and meet all required health criteria for the study.
Select...
I do not have non-secretory multiple myeloma or amyloidosis.
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
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 • NCT0272658134%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2650
Bortezomib
2005
Completed Phase 3
~1410
Elotuzumab
2016
Completed Phase 3
~950
Lenalidomide
2005
Completed Phase 3
~2240
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,059 Total Patients Enrolled
19 Trials studying Multiple Myeloma
7,435 Patients Enrolled for Multiple Myeloma
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
265,474 Total Patients Enrolled
19 Trials studying Multiple Myeloma
7,435 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,025 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,304 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV+ and meet all required health criteria for the study.I do not have POEMS syndrome.My multiple myeloma has not spread to my brain or spinal cord.I have hepatitis B or C but meet specific viral load criteria.I do not have any serious illnesses, including heart problems, high blood pressure, or diabetes.You must have a way for the doctors to measure your disease within 28 days before you join the study.I am HIV positive and meet specific health criteria.I have had a full body X-ray to check my bones.I meet the specific requirements for past chemotherapy and radiotherapy.My blood, liver, and kidney tests meet the required levels.I have no other cancers, or if I do, they were treated successfully.I had a physical exam within the last 28 days.I am able to have children, not pregnant, and agree to use birth control.I have been recently diagnosed with active multiple myeloma.I was diagnosed with high-risk multiple myeloma.I can take care of myself but might not be able to do heavy physical work.I do not have non-secretory multiple myeloma or amyloidosis.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (bortezomib, lenalidomide, dexamethasone, elotuzumab)
- Group 2: Arm I (bortezomib, lenalidomide, dexamethasone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.