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Study Summary
This trial is testing a new drug, TAK-079, for people with multiple myeloma who have already tried other treatments. The goal is to find the best dose of the new drug to give people, and to see how well it works and how safe it is.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 36 Patients • NCT04159805Trial Design
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- Your heart's electrical activity, as shown on a test called an ECG, should not have a specific measurement (QTcF) higher than 470 milliseconds. If the machine shows a higher value, a qualified person should double-check it on another test.I haven't needed strong antibiotics for a serious infection in the last 14 days.I am not allergic to the medication TAK-079 or its components.You have a positive test for HIV, hepatitis B, or hepatitis C in your blood.I have been diagnosed with a specific blood or bone marrow condition.My multiple myeloma shows signs of affecting the lining of my brain.I can take blood thinners while on lenalidomide as advised.I can take care of myself but might not be able to do heavy physical work.I have not had plasmapheresis in the last 28 days.I have multiple myeloma needing treatment, as per IMWG criteria, and haven't been treated yet.I am a suitable candidate for specific myeloma treatments as decided by my doctor.I am not currently in another study or haven't been in one for the last 4 weeks.I have a history of cancer, but it's either been in remission for 2 years, was a minor skin cancer, cervical, bladder, prostate (not aggressive or stable), breast (in situ and fully removed), or thyroid cancer that was treated.I was disqualified from the main study due to not meeting its treatment criteria.I was previously treated with TAK-079 in a Takeda study and the study is closed or about to close.You are expected to live for more than 3 months.I haven't had radiation therapy in the last 14 days, except for pain treatment.I have not had major surgery in the last 4 weeks and have recovered from any surgery-related issues.You must have a certain amount of abnormal proteins in your blood or urine as measured by specific tests.I have had treatment for multiple myeloma, but not including bisphosphonates or a single course of steroids.I am not eligible if my cancer's progress can only be measured by plasmacytoma.
- Group 1: Treatment Phase: TAK-079 and LenDex
- Group 2: Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex)
- Group 3: Treatment Phase: TAK-079 and VRd
- 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.
- 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
What detrimental effects might be linked to the use of TAK-079?
"The safety of TAK-079 is rated as a 1, due to the fact that this early stage clinical trial only has minimal evidence demonstrating its efficacy and security."
Are new participants being recruited for this experiment presently?
"Unfortunately, recruitment for this trial ended on July 27th 2022. There are currently 807 clinical trials that are actively searching for patients with multiple myeloma and 752 studies recruiting participants to take part in TAK-079 research."
What conditions is TAK-079 commonly prescribed to treat?
"TAK-079 is commonly prescribed for ophthalmia and sympathetic. Additionally, it may prove beneficial when treating conditions such as prior systemic chemotherapy regimens, branch retinal vein occlusion, or macular edema."
Are there any reports of prior experiments with TAK-079?
"TAK-079 was first investigated in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, a total of 1640 studies have been completed with 752 active research trials; many are being conducted from Houston, Texas."
To what extent is this research being conducted across various facilities?
"Nine different medical centres are participating in this clinical trial, such as MD Anderson Cancer Center located in Houston, Good Samaritan Hospital of Cincinnati and Oregon Health & Science University situated in Portland. Additionally, 6 other sites are also involved."
How many volunteers are participating in this medical experiment?
"At this moment, the trial is not looking for more participants. It was first posted on July 29th 2019 and last updated on July 27th 2022, so it has closed its recruitment phase. If you're interested in similar studies, 807 trials related to multiple myeloma are open now whilst 752 are recruiting patients with TAK-079 medication."
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