← Back to Search

Proteasome Inhibitor

Elotuzumab + Triple Therapy for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Saad Usmani

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have POEMS syndrome

Patients must not have active involvement of the central nervous system (CNS) with MM

Must not have

Patients who are HIV+ and do not meet specific additional criteria are not eligible for this study

Patients with non-secretory MM or known amyloidosis are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years post registration

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying elotuzumab in combination with lenalidomide, bortezomib, and dexamethasone to treat patients with newly diagnosed multiple myeloma.

Who is the study for?

This trial is for newly diagnosed high-risk multiple myeloma patients without prior malignancies, except certain treated cases. They must not have POEMS syndrome or CNS involvement by MM, and should meet specific blood count and organ function criteria. Women of childbearing age need a negative pregnancy test and agreed birth control measures. Participants must consent to specimen banking for research.

What is being tested?

The study tests if adding Elotuzumab to the combination of Lenalidomide, Bortezomib, and Dexamethasone improves treatment outcomes in high-risk multiple myeloma patients. It's a phase I/II trial that also aims to determine the best dose with acceptable side effects.

What are the potential side effects?

Potential side effects include reactions related to immune response, nerve damage (neuropathy), fatigue, digestive issues like constipation or diarrhea, blood clots, risk of infection due to low white blood cell counts, and possible impact on liver or kidney functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have POEMS syndrome.

Select...

My multiple myeloma has not spread to my brain or spinal cord.

Select...

I do not have any serious illnesses, including heart problems, high blood pressure, or diabetes.

Select...

I meet the specific requirements for past chemotherapy and radiotherapy.

Select...

My blood, liver, and kidney tests meet the required levels.

Select...

I am able to have children, not pregnant, and agree to use birth control.

Select...

I have been recently diagnosed with active multiple myeloma.

Select...

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

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

Select...

I am HIV+ and meet all required health criteria for the study.

Select...

I do not have non-secretory multiple myeloma or amyloidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years post registration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone

Progression-free Survival

Secondary study objectives

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Overall Survival

Response (Partial Response [PR] or Better) Rate

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

Active Control

Group I: Arm II (bortezomib, lenalidomide, dexamethasone, elotuzumab)Experimental Treatment5 Interventions

INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (bortezomib, lenalidomide, dexamethasone)Active Control4 Interventions

INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Bortezomib

2005

Completed Phase 3

~1410