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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
Must not have
Known or suspected Amyloidosis
Active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of one year
Awards & highlights
No Placebo-Only Group

Summary

This trial uses a combination of a special antibody and three drugs to treat newly diagnosed Multiple Myeloma patients who need chemotherapy. The treatment helps the immune system find and kill cancer cells while also using drugs to stop cancer growth.

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.
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.
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 below
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I have newly diagnosed myeloma and need chemotherapy.
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I have been diagnosed with symptomatic multiple myeloma.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or might have Amyloidosis.
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I currently have an infection.
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My cancer has spread to my brain or spinal cord.
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I have high blood pressure or diabetes that is not well-controlled.
Select...
My multiple myeloma shows low or no protein markers before treatment.
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I cannot tolerate elotuzumab, lenalidomide, carfilzomib, or dexamethasone.
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I have a serious heart condition.
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I have been diagnosed with plasma cell leukemia.
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I have had a stroke that left me with lasting nerve damage.
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I have mild to no diarrhea without taking medication for it.
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I have not had major surgery in the last 3 weeks.
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I have had a blood clot in my veins or lungs.
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I haven't been in a drug study within the last 3 weeks or 5 drug half-lives.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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My geriatric assessment score is 2 or higher.
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I have been diagnosed with POEMS syndrome.
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I have Waldenström's macroglobulinemia or IgM myeloma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of one year, adverse events will be monitored in real time
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of one year, adverse events will be monitored in real time for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Duration of response
Number of participants with adverse events of elotuzumab in combination with KRd
Overall survival
+2 more
Other study objectives
Logisitc Regression for analyzing exploratory biomarkers

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

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
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
~1430
Lenalidomide
2005
Completed Phase 3
~2240
Elotuzumab
2016
Completed Phase 3
~950
Dexamethasone
2007
Completed Phase 4
~2650

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Multiple Myeloma include bortezomib, lenalidomide, dexamethasone, and daratumumab. Bortezomib is a proteasome inhibitor that disrupts protein degradation, leading to cancer cell death. Lenalidomide is an immunomodulatory drug that enhances the immune system's ability to attack cancer cells and inhibits their growth. Dexamethasone is a corticosteroid that reduces inflammation and directly kills myeloma cells. Daratumumab is a monoclonal antibody that targets CD38 on myeloma cells, leading to their destruction. These mechanisms are crucial as they target different pathways in myeloma cells, improving treatment efficacy and patient outcomes.

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,466 Previous Clinical Trials
1,401,449 Total Patients Enrolled
97 Trials studying Multiple Myeloma
20,718 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research FoundationOTHER
10 Previous Clinical Trials
3,531 Total Patients Enrolled
10 Trials studying Multiple Myeloma
3,531 Patients Enrolled for Multiple Myeloma
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
840,087 Total Patients Enrolled
19 Trials studying Multiple Myeloma
2,423 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,024 Total Patients Enrolled
91 Trials studying Multiple Myeloma
22,350 Patients Enrolled for Multiple Myeloma
Andrzej Jakubowiak, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
306 Total Patients Enrolled
2 Trials studying Multiple Myeloma
306 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02969837 — Phase 2
Multiple Myeloma Research Study Groups: E-KRd regimen, E-Rd Regimen
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT02969837 — Phase 2
Carfilzomib (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02969837 — Phase 2
~1 spots leftby Mar 2025