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Anti-tumor antibiotic
Drug Combination for Relapsed 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
No Placebo-Only Group
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).
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate by International Myeloma Working Group criteria.
Secondary study objectives
Progression Free Survival
Side effects data
From 2022 Phase 3 trial • 402 Patients • NCT0311056250%
Thrombocytopenia
45%
Anaemia
39%
Nausea
29%
Diarrhoea
29%
Decreased appetite
27%
Weight decreased
24%
Neuropathy peripheral
24%
Vomiting
23%
Fatigue
21%
Neutropenia
21%
Cataract
15%
Asthenia
12%
Upper respiratory tract infection
11%
Constipation
11%
Pyrexia
8%
Oedema peripheral
8%
Pneumonia
6%
Insomnia
6%
Dehydration
6%
Back pain
6%
Leukopenia
6%
Bronchitis
6%
Dizziness
6%
Cough
6%
Lymphopenia
5%
Acute kidney injury
5%
Muscular weakness
5%
Abdominal pain
5%
Lower respiratory tract infection
3%
Sepsis
3%
Hyperglycaemia
3%
Pain in extremity
3%
Urinary tract infection
3%
Nasopharyngitis
3%
Hyponatraemia
3%
Toothache
3%
Disturbance in attention
3%
Cardiac failure
3%
Hypertension
2%
Septic shock
2%
Pulmonary contusion
2%
Peripheral swelling
2%
Infection
2%
Blood creatinine increased
2%
Paraesthesia
2%
Respiratory syncytial virus infection
2%
Dyspepsia
2%
Syncope
2%
Cardiac failure acute
2%
Clostridium difficile infection
2%
Compression fracture
2%
Multiple fractures
2%
Haemoglobin decreased
2%
Myocardial infarction
2%
Cerebral haemorrhage
2%
C-reactive protein increased
2%
Ischaemic stroke
2%
Sudden death
2%
Oropharyngeal pain
2%
Cognitive disorder
2%
Confusional state
2%
Influenza
2%
Osteonecrosis of jaw
2%
Taste disorder
2%
Hyperkalaemia
2%
Blood uric acid increased
2%
Depression
2%
Cerebrovascular accident
2%
Embolism
2%
Bronchitis viral
100%
80%
60%
40%
20%
0%
Study treatment Arm
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SdX Arm: Selinexor + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone
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: 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
~950
Pomalidomide
2011
Completed Phase 2
~1060
Bortezomib
2005
Completed Phase 3
~1410
Dexamethasone
2007
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,897 Total Patients Enrolled
36 Trials studying Multiple Myeloma
2,939 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,131 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,754 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,691 Previous Clinical Trials
4,097,536 Total Patients Enrolled
91 Trials studying Multiple Myeloma
22,362 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,294 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,241 Patients Enrolled for Multiple Myeloma
Andrew J Yee, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
43 Total Patients Enrolled
1 Trials studying Multiple Myeloma
43 Patients Enrolled for Multiple Myeloma