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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

Must not have

Any infection, at the time of screening, requiring systemic therapy

Has a known additional malignancy that is active and/or progressive requiring treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of first response to date of progression/death, or censored as described; assessed for approximately 3 years.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

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I am committed to using two effective birth control methods.

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My blood or urine tests show signs of my disease.

Select...

I have had one round of treatment for multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on medication for an infection.

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I have another cancer that is growing and needs treatment.

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My multiple myeloma has spread to my brain or spinal cord.

Select...

I have had a stroke that left me with lasting neurological issues.

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I do not have HIV or active hepatitis A, B, or C.

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I have a serious illness that is not under control.

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My multiple myeloma does not produce detectable levels of M protein.

Select...

I stopped taking lenalidomide, carfilzomib, or dexamethasone because it didn't agree with me.

Select...

I have been diagnosed with POEMS syndrome.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With VGPR or Better Response to Induction

Secondary study objectives

Duration of Response (DoR)

Number of Subjects With an Objective Response

Overall Survival (OS)

+3 more

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

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

~950

0 / 14Eligibility criteria met