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Anti-tumor antibiotic
Quadruple Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Andrzej Jakubowiak, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed, previously untreated myeloma requiring systemic chemotherapy
Diagnosis of symptomatic multiple myeloma as per current IMWG uniform criteria prior to initial treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of one year
Awards & highlights
Study Summary
This trial is testing a new treatment for Multiple Myeloma that involves 12-24 cycles of chemotherapy. The primary endpoint is the rate of response by next generation gene sequencing at the end of 8 cycles.
Who is the study for?
Adults with newly diagnosed, untreated multiple myeloma who need chemotherapy can join this trial. They must be fit for treatment (ECOG 0-1), not pregnant, and willing to follow birth control requirements. People with certain heart conditions, recent major surgery or therapy, severe neuropathy, or active infections cannot participate.Check my eligibility
What is being tested?
The study tests a combination of Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in patients with multiple myeloma over 12-24 cycles. It's an open-label Phase 2 trial aiming to see how well the treatment works by measuring disease progression or patient survival.See study design
What are the potential side effects?
Possible side effects include immune system reactions, blood clots, high blood pressure from Carfilzomib; skin rash and fatigue from Lenalidomide; infusion-related reactions from Elotuzumab; and increased blood sugar levels and mood changes from Dexamethasone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have newly diagnosed myeloma and need chemotherapy.
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I have been diagnosed with symptomatic multiple myeloma.
Select...
My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion an average of one year, adverse events will be monitored in real time
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of one year, adverse events will be monitored in real time
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of negative MRD
Rate of sCR
Secondary outcome measures
Duration of response
Number of participants with adverse events of elotuzumab in combination with KRd
Overall survival
+3 moreOther outcome measures
Logisitc Regression for analyzing exploratory biomarkers
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%
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
2Treatment groups
Experimental Treatment
Group I: E-Rd RegimenExperimental Treatment3 Interventions
Participants will receive elotuzumab, lenalidomide, and dexamethasone.
Group II: E-KRd regimenExperimental Treatment4 Interventions
Participants will receive elotuzumab, carfilzomib, lenalidomide, and dexamethasone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Lenalidomide
2005
Completed Phase 3
~1480
Elotuzumab
2016
Completed Phase 3
~800
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,641 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,693 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
3,530 Total Patients Enrolled
10 Trials studying Multiple Myeloma
3,530 Patients Enrolled for Multiple Myeloma
University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,803 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,922 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or might have Amyloidosis.I am 18 years old or older.I have not taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.I currently have an infection.I do not have an active HIV, HBV (unless from vaccine), or HCV infection.I have newly diagnosed myeloma and need chemotherapy.I have a serious heart condition.My cancer has spread to my brain or spinal cord.Before starting treatment, you have a disease that can be measured and monitored.I have high blood pressure or diabetes that is not well-controlled.My multiple myeloma shows low or no protein markers before treatment.I cannot tolerate elotuzumab, lenalidomide, carfilzomib, or dexamethasone.Before joining the study, your recent blood tests must show certain levels: white blood cells above 2000, platelets above 75,000, a type of white blood cell called ANC above 1000, hemoglobin above 8.0, and a measure of kidney function within a certain range.Women who could become pregnant must have two negative pregnancy tests before starting lenalidomide.I have been diagnosed with plasma cell leukemia.I have had a stroke that left me with lasting nerve damage.I have mild to no diarrhea without taking medication for it.I have not had major surgery in the last 3 weeks.I have had a blood clot in my veins or lungs.Your heart's electrical activity (shown on a special heart test) is too slow.I have not had plasmapheresis in the last 4 weeks.I haven't been in a drug study within the last 3 weeks or 5 drug half-lives.I have moderate to severe numbness, tingling, or pain in my hands or feet.I haven't had cancer, except for certain skin, thyroid, cervix, or low-grade prostate cancers, in the last 3 years.I've been treated for myeloma complications but haven't exceeded the specified medication limits.I have been diagnosed with symptomatic multiple myeloma.My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.I am fully active or can carry out light work.My geriatric assessment score is 2 or higher.I will use a condom during the study and for 28 days after, even though I've had a vasectomy.I have been diagnosed with POEMS syndrome.I have Waldenström's macroglobulinemia or IgM myeloma.I have not had radiotherapy in the last 14 days, or within 7 days if it was to a single area.My high blood pressure has not been under control for the last 14 days.Your corrected calcium level is higher than 11.5 mg/dL within 2 weeks before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: E-KRd regimen
- Group 2: E-Rd Regimen
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.
Does this trial currently have openings for participants?
"According to clinicaltrials.gov, the recruitment phase of this trial has ended and it is no longer searching for participants. While published on July 10th 2017, the study was last revised November 12th 2021; however, 1516 comparable studies are actively recruiting individuals at present."
Answered by AI
Has Elotuzumab been verified by the FDA?
"Although there is evidence of Elotuzumab's safety, the lack of clinical studies confirming its efficacy results in a score of 2."
Answered by AI
How many individuals are currently receiving treatment as part of this research endeavor?
"This medical trial is no longer recruiting new participants, having been posted first on July 10th 2017 and edited most recently on November 12 2021. If you are searching for similar studies, currently 807 trials related to multiple myeloma and 709 investigations centred around Elotuzumab are actively enrolling patients."
Answered by AI
Can you provide a summary of previous research related to Elotuzumab?
"Elotuzumab was first properly examined in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, 1380 trials have been completed and 709 are presently active; a majority of these studies originate from Evanston, Michigan."
Answered by AI
To what applications is Elotuzumab regularly applied?
"Elotuzumab is most commonly prescribed for ophthalmia, sympathetic but has also been used in treating branch retinal vein occlusion and macular edema. It's generally reserved for patients who have already undergone at least two systemic chemotherapies."
Answered by AI
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