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Targeted Therapy + Standard Treatment for Multiple Myeloma (MyDRUG Trial)
Phase 1 & 2
Waitlist Available
Led By Daniel Auclair, Ph.D.
Research Sponsored by Multiple Myeloma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have progressed after their most recent treatment and require therapy for myeloma
Females of reproductive potential must have a negative pregnancy test at baseline, be non-lactating, and willing to adhere to scheduled pregnancy testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 years
Awards & highlights
MyDRUG Trial Summary
This trial is a precision medicine study to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease.
Who is the study for?
This trial is for adults with Multiple Myeloma who have specific gene mutations, have had at least one but no more than three prior treatments, and are not currently pregnant or breastfeeding. They must be able to take blood thinners and have an ECOG status of 0-2, indicating they can perform daily activities with varying degrees of assistance.Check my eligibility
What is being tested?
The MyDRUG study tests targeted drugs against mutated genes in Multiple Myeloma patients. It uses precision medicine to match treatments like Abemaciclib, Enasidenib, Cobimetinib, Erdafitinib, Venetoclax, Daratumumab, Belantamab mafodotin and Selinexor with the patient's specific genetic profile.See study design
What are the potential side effects?
Potential side effects include fatigue; nausea; risk of infection; blood clots; liver issues; skin reactions such as rash or dryness; gastrointestinal problems like constipation or diarrhea; nerve damage causing numbness or tingling sensations.
MyDRUG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My myeloma has worsened after the last treatment and I need new therapy.
Select...
I am not pregnant, not breastfeeding, and agree to regular pregnancy tests.
Select...
My multiple myeloma can be measured for its progress.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can take aspirin, warfarin, or low molecular weight heparin.
MyDRUG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 years
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 - Actionable Genetic Alteration
Overall Response Rate - Non-Actionable Genetic Alteration
MyDRUG Trial Design
8Treatment groups
Experimental Treatment
Group I: Sub-Protocol Y3Experimental Treatment1 Intervention
Patients with Non-Actionable Genetic Abnormality receive Selinexor in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Group II: Sub-Protocol Y2Experimental Treatment1 Intervention
Patients with Non-Actionable Genetic Abnormality receive Belantamab mafodotin in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Group III: Sub-Protocol Y1Experimental Treatment1 Intervention
Patients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Group IV: Sub-Protocol E1Experimental Treatment1 Intervention
Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Group V: Sub-Protocol D1Experimental Treatment1 Intervention
Patients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Group VI: Sub-Protocol C1Experimental Treatment1 Intervention
Patients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Group VII: Sub-Protocol B1Experimental Treatment1 Intervention
Patients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Group VIII: Sub-Protocol A1Experimental Treatment1 Intervention
Patients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Find a Location
Who is running the clinical trial?
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,177,716 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,005 Patients Enrolled for Multiple Myeloma
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,216,371 Total Patients Enrolled
6 Trials studying Multiple Myeloma
4,447 Patients Enrolled for Multiple Myeloma
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
567,915 Total Patients Enrolled
23 Trials studying Multiple Myeloma
6,270 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious medical or mental health condition, or struggle with alcoholism or drug addiction that could make it hard for you to follow the study guidelines.I have amyloidosis or plasma cell leukemia with symptoms.I do not have any uncontrolled heart conditions.I have been cancer-free for over 3 years, except for minor skin cancers or early-stage cervical, breast, or prostate cancer.My multiple myeloma can be measured for its progress.You have more than 30% of a specific type of cells in your bone marrow.My side effects from previous treatments are mild.I had a stem cell transplant less than 12 weeks ago.Your recent lab test results must meet certain standards.I have previously been treated with Ixazomib, Pomalidomide, and Dexamethasone.I have POEMS syndrome.I haven't had cancer treatment in the last 14 days.I haven't had major surgery or radiation therapy in the last 4 weeks.My multiple myeloma is aggressive and needs immediate treatment.I haven't needed antibiotics for an infection in the last 2 weeks.I am willing to enroll in the POMALYST REMS program.I am not pregnant, not breastfeeding, and agree to regular pregnancy tests.You have had a bad reaction or skin rash to certain medications.I do not have active hepatitis or HIV.I can take care of myself and am up and about more than half of my waking hours.I can take aspirin, warfarin, or low molecular weight heparin.I have a condition that affects my ability to swallow or absorb pills.My myeloma has worsened after the last treatment and I need new therapy.You have recently participated in a specific medical test called the MMRF002 Molecular Profiling Protocol.I have multiple myeloma, treated 1-3 times before, but it came back quickly.
Research Study Groups:
This trial has the following groups:- Group 1: Sub-Protocol E1
- Group 2: Sub-Protocol Y1
- Group 3: Sub-Protocol D1
- Group 4: Sub-Protocol Y2
- Group 5: Sub-Protocol Y3
- Group 6: Sub-Protocol A1
- Group 7: Sub-Protocol B1
- Group 8: Sub-Protocol C1
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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.
Are there any historical instances of research on this combination of drugs?
"The drug combination of Daratumumab, dexamethasone, ixazomib, and pomalidomide was first studied in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. So far, 1322 trials have been completed with this medication. There are presently 1102 live studies being conducted across the world; a significant portion of these are based out of Boston, Massachusetts."
Answered by AI
At how many different hospitals is this clinical trial taking place?
"So far, this study has recruited patients from 16 different locations including hospitals in Boston, Detroit, and Phoenix."
Answered by AI
How is Daratumumab, dexamethasone, ixazomib, pomalidomide typically used?
"Daratumumab, dexamethasone, ixazomib, and pomalidomide are often used to treat ophthalmia and sympathetic. Additionally, this medication can help patients that suffer from branch retinal vein occlusion, macular edema, or communicable diseases."
Answered by AI
Are patients being actively sought for this research project?
"That is correct, the information available on clinicaltrials.gov implies that this study is still looking for participants. The trial was originally advertised on April 1st, 2019 and updated September 9th, 2021. In total, 228 patients are needed at 16 different locations."
Answered by AI
What is the total number of people who will be participating in this research?
"That is accurate. The listing on clinicaltrials.gov indicates that the research team is looking for new participants. This trial was first announced on April 1st, 2019 and received its latest update on September 9th, 2021. There are currently 16 different centres enrolling a total of 228 patients."
Answered by AI
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