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Proteasome Inhibitor

Elotuzumab for Multiple Myeloma

Phase 2
Waitlist Available
Led By Jacob P. Laubach, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is a candidate for high-dose therapy and autologous SCT based on standard criteria at the institution where this treatment will be administered.
Newly diagnosed untreated, symptomatic, documented MM based on standard diagnostic criteria (Rajkumar 2009) with measurable disease, defined as any of the following: Serum Immunoglobulin G (IgG), Immunoglobulin (A) IgA, or Immunoglobulin M (IgM) M-protein ≥ 0.5 g/dL, or Serum Immunoglobulin D (IgD) M-protein ≥ 0.05 g/dL, or Urinary M-protein excretion of more than 200 mg/24 hours, or Serum free light chains (FLC) of at least 100 mg/dL with an abnormal FLC ratio
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the most distant time of stem cell mobilization from time of registration is 21.4 weeks with a median of 15.14 weeks.
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat multiple myeloma.

Who is the study for?
This trial is for adults over 18 with newly diagnosed, untreated multiple myeloma who can follow the study plan. They must have measurable disease and be fit enough for stem cell transplant. Women of childbearing age must test negative for pregnancy and use two birth control methods; men must use condoms. Participants cannot have severe kidney issues, low blood counts, recent major surgery, other cancers within 5 years (except certain skin/cervical cancers), or known allergies to study drugs.Check my eligibility
What is being tested?
The trial tests a combination therapy using four drugs: lenalidomide, bortezomib, dexamethasone, and elotuzumab in patients with new multiple myeloma. It aims to evaluate the effectiveness of this drug regimen as initial treatment before stem cell mobilization and transplant.See study design
What are the potential side effects?
Possible side effects include nerve damage (neuropathy), blood clots, lowered immunity leading to infections, fatigue from anemia or treatment itself, digestive problems like constipation or diarrhea due to medication effects on the stomach lining or bowel movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a stem cell transplant according to my hospital's rules.
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I have been diagnosed with multiple myeloma and have not started treatment.
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I agree not to donate blood during and for 8 weeks after my treatment.
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I am 18 years old or older, or at the legal age of consent.
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I am committed to following strict birth control measures if I'm of childbearing potential or will use a condom if I'm a man.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the most distant time of stem cell mobilization from time of registration is 21.4 weeks with a median of 15.14 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the most distant time of stem cell mobilization from time of registration is 21.4 weeks with a median of 15.14 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
4 Cycle Response Rate
Secondary outcome measures
4 Cycle Ever Dose Modification (DM) Rate
Best Responses to E-RVD.
Grade 3 and 4 Treatment-Emergent Adverse Event (TEAE) Rate
+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%
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: Elotuzumab, lenalidomide, bortezomib, and dexamethasoneExperimental Treatment5 Interventions
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. Elotuzumab will be administered by intravenous (IV) infusion Bortezomib as a subcutaneous injection Lenalidomide single daily oral dose Dexamethasone as oral tablets and IV infusion Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Induction Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive a full 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 2
~1140
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Elotuzumab
2016
Completed Phase 3
~800

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,276 Total Patients Enrolled
84 Trials studying Multiple Myeloma
29,638 Patients Enrolled for Multiple Myeloma
Dana-Farber Cancer InstituteLead Sponsor
1,071 Previous Clinical Trials
340,324 Total Patients Enrolled
51 Trials studying Multiple Myeloma
34,282 Patients Enrolled for Multiple Myeloma
Jacob P. Laubach, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
14 Total Patients Enrolled
1 Trials studying Multiple Myeloma
14 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

What is the current size of this medical experiment?

"At the moment, this clinical trial is not recruiting. It was first posted on May 7th 2015 and last updated on December 17 2021. If you're searching for alternatives studies, there are 807 trials currently enrolling patients with multiple myeloma as well as 738 prospective Elotuzumab studies seeking participants."

Answered by AI

How prevalent is this medical investigation across the state?

"Patients are being recruited at the moment from 7 sites, with Boston, Hackensack and Saint Louis among them. It is prudent to select a site nearby in order to limit your required travel if accepted into this trial."

Answered by AI

Are there other experiments that have utilized Elotuzumab?

"First documented in 2002, elotuzumab has been the subject of 1614 clinical trials and currently 738 studies remain active. Many of these investigations are based out of Boston, Massachusetts."

Answered by AI

What clinical indications does Elotuzumab typically address?

"Elotuzumab is a valuable treatment for ailments such as ophthalmia, sympathetic and branch retinal vein occlusion. Moreover, it can be helpful to patients who have had at least two rounds of systemic chemotherapy regimens or are suffering from macular edema."

Answered by AI

Has Elotuzumab been given the greenlight by the FDA?

"There is limited data available to evaluate elotuzumab's safety, so it receives an estimated score of 2."

Answered by AI

Are there any opportunities to join this clinical trial at present?

"At present, this trial is not in the process of enrolling patients. It was first put up on May 7th 2015 and updated December 17th 2021; however, if one wishes to investigate other studies related to multiple myeloma or Elotuzumab there are 807 and 738 trials respectively that are actively searching for participants."

Answered by AI
~4 spots leftby Mar 2025