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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
Patients whose primary therapy was changed due to suboptimal response or toxicity will be eligible, with a limit of no more than 2 regimens prior to ASCT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I changed my primary cancer treatment due to poor response or side effects, but haven't tried more than 2 treatments before stem cell transplant.
Select...
I had a stem cell transplant within 18 months after starting treatment for newly diagnosed myeloma.
Select...
I can start maintenance therapy between 60 to 210 days after my transplant, meeting specific health criteria.
Select...
I meet the study's requirements for contraception or am not of childbearing potential.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival
Secondary outcome measures
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%
Back pain
21%
Constipation
21%
Oedema peripheral
21%
Dyspnoea
17%
Nasopharyngitis
17%
Asthenia
17%
Cough
16%
Nausea
16%
Insomnia
16%
Thrombocytopenia
16%
Muscle spasms
14%
Dizziness
14%
Decreased appetite
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%
Pain
9%
Lymphocyte count decreased
9%
Neuropathy peripheral
9%
Malignant neoplasm progression
9%
Vomiting
9%
Neutrophil count decreased
9%
Hypokalaemia
9%
Tremor
9%
Confusional state
9%
Respiratory tract infection
9%
Bone pain
7%
Urinary tract infection
7%
Bronchitis
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%
Hypoaesthesia
3%
Pulmonary embolism
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%
Peripheral sensory neuropathy
1%
Skin laceration
1%
Myocardial infarction
1%
Rhinovirus infection
1%
Dehydration
1%
Alopecia
1%
Cytomegalovirus viraemia
1%
Diverticulitis
1%
Erysipelas
1%
Escherichia urinary tract infection
1%
Gastroenteritis
1%
Hand-foot-and-mouth disease
1%
Pneumonia fungal
1%
Pneumonia legionella
1%
Pulmonary sepsis
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%
Cerebral thrombosis
1%
Encephalopathy
1%
Haemorrhage intracranial
1%
Renal failure
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
1%
Urinary retention
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

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
Lenalidomide
2005
Completed Phase 3
~1480
Elotuzumab
2016
Completed Phase 3
~800

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,226 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,724 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,162 Total Patients Enrolled
572 Trials studying Multiple Myeloma
187,872 Patients Enrolled for Multiple Myeloma
Sheeba ThomasPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Elotuzumab Clinical Trial Eligibility Overview. Trial Name: NCT02420860 — Phase 2
Multiple Myeloma Research Study Groups: Treatment (elotuzumab, lenalidomide)
Multiple Myeloma Clinical Trial 2023: Elotuzumab Highlights & Side Effects. Trial Name: NCT02420860 — Phase 2
Elotuzumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT02420860 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment currently taking place?

"The information stored on clinicaltrials.gov suggests that this particular medical trial is not actively recruiting patients at present, despite having been first posted in April 2015 and last updated in September 2022. However, 1103 other studies are currently enrolling participants."

Answered by AI

To what extent does Elotuzumab present a risk to those using it?

"Our team assigned Elotuzumab a score of 2, as this is still in the Phase 2 stage with limited data on its efficacy but some evidence supporting safety."

Answered by AI

How many individuals are being included in this clinical investigation?

"At this current juncture, the trial is not actively enrolling patients. It was initially posted on April 14th 2015 and last updated on September 22nd 2022. If you're searching for other research opportunities, there are 824 clinical trials related to hematopoietic cell transplantation recipient enrolment and 279 studies with Elotuzumab recruiting individuals right now."

Answered by AI

To what afflictions is elotuzumab commonly prescribed?

"Elotuzumab is usually indicated for multiple myeloma treatment, but can also be employed to treat relapsed and/or refractory lymphoma, chronic lymphocytic leukemia, or in cases where two prior systemic chemotherapy regimens have been unsuccessful."

Answered by AI
~12 spots leftby Apr 2025