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Monoclonal Antibodies
GSK2857916 + Pomalidomide + Dexamethasone for Multiple Myeloma
Phase 1 & 2
Recruiting
Research Sponsored by Canadian Myeloma Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Previously treated with two or more prior lines of treatment that must have included lenalidomide and a proteasome inhibitor (in separate regimens or in combination)
Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study Summary
This trial will test a new drug (GSK2857916) given with pomalidomide and dexamethasone to see if it is safe and effective in people with relapsed or refractoryMultiple Myeloma.
Who is the study for?
Adults with relapsed or refractory Multiple Myeloma who've had at least two prior treatments including lenalidomide and a proteasome inhibitor, can take oral medications, use effective contraception, and have no severe medical conditions that could affect safety. They must not be pregnant, have used certain myeloma therapies before, or have serious heart problems.Check my eligibility
What is being tested?
The trial is testing the combination of GSK2857916 (an IV drug), Pomalidomide (a pill), and low-dose Dexamethasone (also a pill) to see if they're safe together and work well for treating Multiple Myeloma in patients who haven't responded to other treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to the infusion process, changes in blood counts leading to increased risk of infections or bleeding, fatigue, digestive issues like nausea or constipation, hormonal imbalances affecting mood or weight gain due to steroids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been treated with lenalidomide and a proteasome inhibitor.
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I can care for myself and am up and about more than 50% of my waking hours.
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My multiple myeloma has come back or is not responding to treatment.
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I have had a stem cell transplant or am not eligible for one.
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I am 18 years old or older.
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I do not have any current infections.
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I agree to use effective birth control during and up to 4-5 months after treatment.
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My multiple myeloma worsened after initially responding or staying stable with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Maximum tolerated dose (MTD)
Progression Free Survival
Treatment Emergent Adverse Events
Trial Design
1Treatment groups
Experimental Treatment
Group I: GSK2857916 with Pomalidomide and DexamethasoneExperimental Treatment1 Intervention
This will be a single arm study of GSK2857916 administered with pomalidomide and dexamethasone. GSK2857916 will be administered intravenously either on Day 1 of each 28 day cycle (Single Dose) or on Days 1 and 8 (Split Dose) and up to 4 dose levels will be evaluated during the phase I portion. Pomalidomide will be administered orally on Days 1-21 at 4 mg. Dexamethasone will be administered orally at 40 mg for patients ≤ 75 years old or 20 mg for patients older than 75 on days 1, 8, 15, 22.
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Who is running the clinical trial?
Canadian Myeloma Research GroupLead Sponsor
6 Previous Clinical Trials
383 Total Patients Enrolled
6 Trials studying Multiple Myeloma
383 Patients Enrolled for Multiple Myeloma
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,568 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,313 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take pills by mouth.Your blood test for liver function shows ALT levels within a certain range.I haven't taken any experimental drugs or monoclonal antibodies recently.I can care for myself and am up and about more than 50% of my waking hours.Your heart's electrical activity takes longer than normal to recharge between beats.Your albumin level is at least 20 grams per liter.I am currently on treatment for an active infection.Your hemoglobin level should be 80 grams per liter or higher.I have significant nerve pain or tingling that hasn't improved with treatment.My liver condition is stable and does not include severe symptoms like ascites or jaundice.I do not have any active kidney problems that could affect my safety in the trial, except for protein in my urine due to my condition.Your blood test shows a high level of M-protein (a type of protein).I am committed to following strict birth control or abstinence as required.I have another cancer type, but it's stable and not being actively treated, except with hormones.I can take daily aspirin or an alternative if I'm allergic.I have not had major surgery in the last 4 weeks.My multiple myeloma has come back or is not responding to treatment.You have had a bad reaction to drugs similar to GSK2857916 or its ingredients in the past.My platelet count is above 75 without recent transfusions.I haven't had a heart attack or heart surgery in the last 6 months.I cannot tolerate prednisone or dexamethasone at the full starting dose.Your albumin/creatinine ratio in your urine is less than 500mg/g (56 mg/mmol).Your kidney function, measured by eGFR, needs to be at least 40 mL/min.Your blood test shows high levels of certain proteins called free light chains and an abnormal ratio of these proteins.You must have a measurable disease, which means that the disease can be accurately measured and evaluated.All my previous treatment side effects are mild or considered permanent, except for hair loss.My blood pressure is not well-controlled.My transplant was over 100 days ago.I have had a stem cell transplant or am not eligible for one.I've been treated with lenalidomide and a proteasome inhibitor.I do not have serious heart rhythm problems.I am allergic to thalidomide, lenalidomide, or cannot tolerate dexamethasone, except for manageable rashes.I have a mild eye condition but no serious corneal disease.I do not have severe heart failure.I have hepatitis B but am on prophylaxis and have a negative Hepatitis B DNA test.I am 18 years old or older.I have tested positive for hepatitis C or had it in the past but now cleared.I am currently experiencing bleeding from an internal organ or mucosa.I have previously used pomalidomide or BCMA therapy.I haven't had radiotherapy or systemic therapy in the last 14 days.I had a stem cell transplant and meet specific health criteria.You have too much M-protein in your urine.Signs of heart problems such as:
- High blood pressure
- Heart disease
- Previous heart attack or strokeI do not have any current infections.I agree to use effective birth control during and up to 4-5 months after treatment.My multiple myeloma worsened after initially responding or staying stable with treatment.My white blood cell count is healthy and I haven't taken G-CSF in the last 10 days.You have had a transplant using cells from a donor.My bilirubin levels are within the normal range, or I have Gilbert's disease with specific bilirubin levels.
Research Study Groups:
This trial has the following groups:- Group 1: GSK2857916 with Pomalidomide and Dexamethasone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has GSK2857916 ever been trialed alongside Pomalidomide and Dexamethasone before?
"At present, 587 clinical trials are being conducted to investigate GSK2857916 combined with Pomalidomide and Dexamethasone. Of those, 145 have progressed to Phase 3 while the rest remain in earlier phases of research. Most of these studies take place at a single location in Joliet, Illinois; however, there are 19043 sites worldwide running trails on this potential treatment option."
Answered by AI
What is the total participant count of this research initiative?
"The study, sponsored by GlaxoSmithKline and conducted across multiple sites, requires 96 patients who meet the set inclusion criteria. These locations include Allan Blair Cancer Centre in Regina, Saskatchewan and QEII Health Sciences Centre in Halifax, Nova Scotia."
Answered by AI
In which locations is this study being conducted?
"This trial has multiple centres of operations, namely the Allan Blair Cancer Centre in Regina (Saskatchewan), QEII Health Sciences Centre in Halifax (Nova Scotia) and Princess Margaret Cancer Centre in Toronto (Manitoba). Also participating are 9 other medical sites."
Answered by AI
What has been the primary application for GSK2857916 in conjunction with Pomalidomide and Dexamethasone?
"Ophthalmia, sympathetic is usually managed through the combined use of GSK2857916 with Pomalidomide and Dexamethasone. This medication also has a positive effect on branch retinal vein occlusion, macular edema, and communicable diseases."
Answered by AI
Is enrolment for this medical trial still open to participants?
"The study is still in search of participants, as reported on clinicaltrials.gov; it was originally posted on the 26th November 2018 and has been modified most recently 2/14/2022."
Answered by AI
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