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Anti-tumor antibiotic
Bortezomib for Multiple Myeloma
Phase 2
Waitlist Available
Led By Andrew J Yee, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a mix of drugs to see if they can help treat Multiple Myeloma that has come back after treatment or has not responded to treatment. The drugs being studied are elotuz
Who is the study for?
This trial is for adults over 18 with relapsed Multiple Myeloma who have had at least one prior therapy including lenalidomide and a proteasome inhibitor. Participants must have measurable disease indicators, such as specific levels of monoclonal protein in blood or urine, and be physically able to perform daily activities (ECOG ≤ 2).Check my eligibility
What is being tested?
The study tests a combination treatment for Multiple Myeloma using Elotuzumab, Pomalidomide, Bortezomib, and Dexamethasone. It aims to find out how effective this drug mix is for those whose cancer has returned after previous treatments.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, fatigue, nausea, nerve damage causing pain or numbness (neuropathy), increased risk of infections due to low blood cell counts, and possible steroid-related issues like mood swings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall response rate by International Myeloma Working Group criteria.
Secondary outcome measures
Progression Free Survival
Side effects data
From 2008 Phase 2 trial • 20 Patients • NCT00006184100%
Injection site reaction
40%
Fatigue (asthenia, lethargy, malaise)
30%
Pruritus
30%
Platelets
30%
Chest pain (non-cardiac and non-pleuritic)
30%
Bone pain
30%
Headache
30%
Myalgia (muscle ache)
30%
SGPT (ALT)
30%
Abdominal pain or cramping
20%
Alkaline phosphatase
20%
Hypokalemia
20%
Dizziness/lightheadedness
20%
Arthralgia (joint pain)
20%
Hypomagnesemia
20%
Pain - Other
20%
Rash/desquamation
20%
Rigors/chills
20%
SGOT (AST)
10%
Hypoalbuminemia
10%
Hypocalcemia
10%
Hot flashes/flushes
10%
Hypophosphatemia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
10%
Lymphopenia
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Dry skin
10%
Constipation
10%
Hypotension
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Hypercalcemia
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Hematologic-Other (Splenomegaly in donor-resolved)
10%
Dyspnea (shortness of breath)
10%
Rash/desquamation for BMT
10%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor - Vaccination Generation Group
Recipient - Chemotherapy Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Elotuzumab, pomalidomide, bortezomib, dexExperimental Treatment4 Interventions
Each cycle is 28 days.
Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1.
Pomalidomide will be given orally on days 1-21.
Bortezomib will be given weekly subcutaneously on days 1, 8, 15.
Dexamethasone will be given as a combination orally and intravenously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elotuzumab
2016
Completed Phase 3
~800
Pomalidomide
2011
Completed Phase 2
~1020
Bortezomib
2005
Completed Phase 2
~1090
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,937 Previous Clinical Trials
13,198,998 Total Patients Enrolled
35 Trials studying Multiple Myeloma
2,586 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
637 Previous Clinical Trials
129,462 Total Patients Enrolled
143 Trials studying Multiple Myeloma
41,429 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,645 Previous Clinical Trials
4,130,947 Total Patients Enrolled
88 Trials studying Multiple Myeloma
30,486 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.
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