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An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
EU CTIS ID: 2022-501522-38-00
What this study is testing
To obtain long-term safety data for subjects from ongoing venetoclax studies
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has completed a prior venetoclax study, and the investigator believes that continued treatment with venetoclax is in the best interest of the patient.
- Subjects are willing or able to comply with procedures required in this protocol.
- Subjects entering the extension study with multiple myeloma must adhere to the following guidelines: • All subjects receiving treatment with venetoclax in combination with a proteasome inhibitor must receive prophylaxis with antibiotics while on treatment and for at least 30 days after discontinuation of the proteasome inhibitor and/or venetoclax including: Bactrim forte® (1 tablet, 3 times a week) or equivalent antibiotic therapy AND Amoxicillin clavulanate (500 mg to 1 g, twice daily) or levofloxacin (500 mg once daily, adjusted for renal function) or equivalent antibiotic therapy per institutional guidelines
- Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Subjects agree to abide by protocol-mandated pregnancy avoidance measures.
You likely can't join if
- Female who is pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.
- Male who is considering fathering a child or donating sperm during the study and for approximately 90 days after the last dose of study drug.
- Subjects receiving any live vaccines during study participation including until at least 4 weeks (for all indications except MM) and 8 weeks (for subjects with MM) after the last dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- New Zealand
- Turkey
- Taiwan
- Australia
- United States
- Mexico
- United Kingdom
- Russian Federation
- Korea, Republic of
- Ukraine
- Canada
- Brazil
- Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; New Zealand; Turkey; Taiwan; Australia; United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.