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Elotuzumab + Lenalidomide for Multiple Myeloma

Phase 2

Waitlist Available

Led By Sheeba Thomas

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2

Be older than 18 years old

Must not have

Known active central nervous system involvement

Known active hepatitis B virus hepatitis, or known active hepatitis C virus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well elotuzumab works with lenalidomide as maintenance therapy after transplant in patients with newly diagnosed multiple myeloma who underwent transplant using their own stem cells.

Who is the study for?

This trial is for patients with newly diagnosed multiple myeloma who have had a stem cell transplant using their own cells. Participants should be relatively healthy (ECOG status 0-2), able to follow contraception guidelines or abstain from sex, and must start the therapy within a certain time frame after transplant. They can't join if they've had major surgery or radiation recently, active hepatitis, infections needing IV antibiotics, allergies to study drugs, CNS involvement, trouble swallowing pills, are pregnant/lactating, or haven't recovered from previous treatments.

What is being tested?

The trial tests elotuzumab combined with lenalidomide as maintenance therapy post-autologous stem cell transplant in treating multiple myeloma. The goal is to see if this combination helps prevent cancer recurrence by enhancing the immune system's response and inhibiting cancer growth compared to standard treatment.

What are the potential side effects?

Possible side effects include immune reactions like infusion-related symptoms and organ inflammation; blood disorders; fatigue; digestive issues due to lenalidomide; and potential risks associated with hormonal changes due to required contraception methods.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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My cancer has spread to my brain or spinal cord.

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I have active hepatitis B or C.

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I still have mild or no side effects from my last chemotherapy.

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I haven't needed IV antibiotics in the last 7 days.

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I have not had radiotherapy in the last 14 days.

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I have not had major surgery in the last 2 weeks.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival

Secondary study objectives

Incidence of new primary malignancy

Incidence of toxicity

Overall survival

+1 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: Treatment (elotuzumab, lenalidomide)Experimental Treatment3 Interventions

Patients receive elotuzumab IV over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide PO on days 1-28. 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

Elotuzumab

2016

Completed Phase 3

~910

Lenalidomide

2005

Completed Phase 3

~2240