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Monoclonal Antibodies
Combination Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Saad Usmani, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Documented history of relapsed and/or refractory multiple myeloma per IMWG 2016 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start date to date of next treatment, or censored as described; assessed for approximately 3 years.
Awards & highlights
Study Summary
This trial will study how well a combination of drugs, elotuzumab, carfilzomib, lenalidomide, and dexamethasone, work in treating patients with relapsed or refractory multiple myeloma.
Who is the study for?
Adults with relapsed/refractory multiple myeloma who've had only one prior treatment can join. They must be in decent health, not pregnant, willing to use contraception, and have no major illnesses or surgeries recently. People with certain types of MM, CNS involvement, uncontrolled illness, recent investigational drug use or known allergies to the drugs are excluded.Check my eligibility
What is being tested?
The trial tests a combination of elotuzumab with carfilzomib, lenalidomide and dexamethasone in patients whose multiple myeloma has returned after treatment. This four-drug combo is experimental and aims to see how well it works together for this condition.See study design
What are the potential side effects?
Potential side effects include immune system reactions, fatigue, nausea, risk of infections due to low blood cell counts; heart problems might occur due to previous treatments' influence on cardiac function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
My multiple myeloma has returned or didn't respond to treatment.
Select...
I am committed to using two effective birth control methods.
Select...
My blood or urine tests show signs of my disease.
Select...
I have had one round of treatment for multiple myeloma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With VGPR or Better Response to Induction
Secondary outcome measures
Duration of Response (DoR)
Number of Subjects With an Objective Response
Overall Survival (OS)
+3 moreSide 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%
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
9%
Lymphocyte count decreased
9%
Pain
9%
Vomiting
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%
Urinary tract infection
7%
Bronchitis
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%
Hyperuricaemia
4%
Hyperkalaemia
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%
Rhinovirus infection
1%
Renal failure
1%
Skin laceration
1%
Cerebral thrombosis
1%
Urinary retention
1%
Myocardial infarction
1%
Hand-foot-and-mouth disease
1%
Pulmonary sepsis
1%
Peripheral sensory neuropathy
1%
Dehydration
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
1Treatment groups
Experimental Treatment
Group I: KRd-ElotuzumabExperimental Treatment1 Intervention
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m^2, Day 1 of Cycle 1; @ 56 mg/m^2, Day 8,15 of Cycle 1; @ 56 mg/m^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if <15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elotuzumab
2016
Completed Phase 3
~800
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,192 Total Patients Enrolled
17 Trials studying Multiple Myeloma
3,236 Patients Enrolled for Multiple Myeloma
Saad Z. Usmani, MDLead Sponsor
4 Previous Clinical Trials
51 Total Patients Enrolled
4 Trials studying Multiple Myeloma
51 Patients Enrolled for Multiple Myeloma
Manisha BhutaniLead Sponsor
1 Previous Clinical Trials
39 Total Patients Enrolled
1 Trials studying Multiple Myeloma
39 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to get out of my bed or chair and move around.I am currently on medication for an infection.I have another cancer that is growing and needs treatment.My multiple myeloma has spread to my brain or spinal cord.I have had a stroke that left me with lasting neurological issues.I do not have HIV or active hepatitis A, B, or C.My multiple myeloma has returned or didn't respond to treatment.My multiple myeloma does not produce detectable levels of M protein.I am committed to using two effective birth control methods.I have not had major surgery in the last 4 weeks.I have not undergone plasmapheresis in the last 4 weeks.I am 18 years old or older.I have completed all previous cancer treatments.My heart pumps well, with an ejection fraction of 45% or higher.I have a serious illness that is not under control.I have recovered from side effects of previous treatments to my normal health level or mild symptoms.My blood or urine tests show signs of my disease.I am a woman who can have children, have tested negative for pregnancy, and agree to regular pregnancy tests.I stopped taking lenalidomide, carfilzomib, or dexamethasone because it didn't agree with me.I can follow the study's procedures for its duration.My condition worsened or did not improve within 60 days after finishing carfilzomib treatment.I am a man willing to use condoms during and 180 days after treatment if sexually active with a woman who can become pregnant.I have been diagnosed with POEMS syndrome.My organs are functioning well enough for treatment.I have had one round of treatment for multiple myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: KRd-Elotuzumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other examples of Elotuzumab being used in a clinical setting?
"At present, there are 23 clinical trials underway that focus on elotuzumab. Three of those trials are in the third and final phase. The majority of studies related to elotuzumab take place in Houston, Texas; however, there are 857 total locations across the United States where these trials are occurring."
Answered by AI
Are we looking for more test subjects at this time?
"Currently, this clinical trial is not looking for new participants. The study was first posted on December 15th 2017 and edited more recently on August 31st 2022. 827 other trials are currently enrolling patients with multiple myeloma while 23 different trials are recruiting patients that hope to receive Elotuzumab."
Answered by AI
What goal does this experiment hope to achieve?
"The primary outcome that will be measured in this clinical trial is VGPR+. The trial sponsor, Bristol-Myers Squibb, has reported that the median length of induction for this trial is 16 weeks. Secondary outcomes that will be measured include Progression Free Survival (PFS), Time to Disease Progression (TTP), and Duration of Response (DoR)."
Answered by AI
How does Elotuzumab compare in safety to other treatments?
"While there is some data supporting the safety of Elotuzumab, it has not yet been proven to be effective. Consequently, we've given it a score of 2."
Answered by AI
How many people are allowed to be part of this experiment at one time?
"Presently, this clinical trial is not searching for any new participants. The most recent update to the study was on August 31st, 2022. However, there are 827 other trials actively recruiting patients with multiple myeloma and 23 more seeking individuals specifically for Elotuzumab treatment."
Answered by AI
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