What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib, dexamethasone, cyclophosphamide, lenalidomide, and carfilzomib, are associated with a range of side effects. Frequently reported adverse events include infections, fatigue, gastrointestinal issues (nausea, vomiting, diarrhea, constipation), neuropathy, and hematologic toxicities like neutropenia, thrombocytopenia, and anemia. Other notable side effects can include hypertension, cardiac events, renal failure, and dermatologic reactions. These side effects vary in severity and frequency depending on the specific drug combination and patient condition.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, including bortezomib (a proteasome inhibitor), lenalidomide (an immunomodulatory drug), and dexamethasone (a corticosteroid). These drugs are often used in combination regimens. Daratumumab, a monoclonal antibody targeting CD38, has also been approved and is frequently combined with other agents like bortezomib and dexamethasone. These treatments are part of both cytotoxic and targeted therapy approaches, aiming to improve patient outcomes by leveraging different mechanisms of action.

What other types of research exist?

Promising novel alternatives to traditional chemotherapy for Multiple Myeloma patients include combination therapies involving bortezomib, daratumumab, and dexamethasone. Specifically, regimens such as daratumumab plus bortezomib and dexamethasone, and carfilzomib, dexamethasone, and daratumumab have shown encouraging results in clinical trials. These combinations have demonstrated improved response rates and progression-free survival compared to traditional chemotherapy regimens.

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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.

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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 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

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

Lymphocyte count decreased

Vomiting

Pain

Neuropathy peripheral

Malignant neoplasm progression

Neutrophil count decreased

Hypokalaemia

Tremor

Confusional state

Respiratory tract infection

Bone pain

Bronchitis

Urinary tract infection

Abdominal pain

Abdominal distension

Dry mouth

Cataract

Paraesthesia

Wheezing

Chest pain

Chills

Non-cardiac chest pain

Hypophosphataemia

Muscular weakness

Musculoskeletal chest pain

Myalgia

Anxiety

Chronic kidney disease

Dysphonia

Nasal congestion

Pruritus

Blood creatinine increased

Acute kidney injury

Hyperkalaemia

Hyperuricaemia

Febrile neutropenia

Influenza

Fall

Hypercalcaemia

Pain in extremity

Epistaxis

Sepsis

Hypocalcaemia

Pulmonary embolism

Hypoaesthesia

Leukopenia

Humerus fracture

Plasma cell myeloma

Syncope

Respiratory failure

Sinusitis

Alanine aminotransferase increased

Productive cough

Atrial fibrillation

Septic shock

Vision blurred

Cardiac failure

Aspartate aminotransferase increased

Hyponatraemia

Myocardial infarction

Pulmonary sepsis

Hand-foot-and-mouth disease

Rhinovirus infection

Skin laceration

Cerebral thrombosis

Renal failure

Dehydration

Peripheral sensory neuropathy

Urinary retention

Alopecia

Cytomegalovirus viraemia

Diverticulitis

Erysipelas

Escherichia urinary tract infection

Gastroenteritis

Pneumonia fungal

Pneumonia legionella

Atrioventricular block complete

Cardiac arrest

Cardiac failure acute

Sinus node dysfunction

Vertigo

Condition aggravated

Respiratory syncytial virus infection

Hypersensitivity

Bacteraemia

Cellulitis

Wound infection

Femur fracture

Lower limb fracture

Lung cancer metastatic

Encephalopathy

Haemorrhage intracranial

Renal impairment

Acute respiratory failure

Dyspnoea exertional

Deep vein thrombosis

Lymphopenia

Pancytopenia

Sinus bradycardia

Hyperthyroidism

Candida infection

Neck pain

Atelectasis

Hypoxia

Hypotension

Infection

Plasmacytoma

Refractory cytopenia with unilineage dysplasia

Hypovolaemic shock

Impaired healing

Post procedural complication

Arthritis

100%

80%

60%

40%

20%

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

~910

Dexamethasone

2007

Completed Phase 4

~2650

0 / 21Eligibility criteria met

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.