Your session is about to expire
← Back to Search
Immunomodulatory Agent
Vactosertib + Pomalidomide for Multiple Myeloma
Phase 1
Waitlist Available
Led By Koen van Besien, MD, PhD
Research Sponsored by Koen van Besien
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 up to 30 days after treatment ends (24 weeks + 30 days)
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of Vactosertib when given with Pomalidomide to people with Multiple Myeloma who have previously been treated.
Who is the study for?
This trial is for adults with multiple myeloma that has come back or hasn't responded to treatment. They must have tried a proteasome inhibitor and IMiD therapy before, be in fairly good health (ECOG ≤ 2), and not planning on stem cell transplant soon. Women who can get pregnant and men must agree to use birth control.Check my eligibility
What is being tested?
The study tests Vactosertib's safety and the best dose when combined with Pomalidomide (POM) in treating multiple myeloma. It aims to find out if this combo helps patients whose disease returned or resisted previous treatments.See study design
What are the potential side effects?
Potential side effects of Vactosertib with Pomalidomide may include but are not limited to allergic reactions, blood clots, bone marrow suppression leading to low blood counts, fatigue, nausea, diarrhea, risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after discontinuation of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after discontinuation of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the maximum tolerated dose (MTD) or maximum tested dose level of Vactosertib given in combination with POM for the treatment of relapsed or RRMM
Secondary outcome measures
Duration of Response
Overall Survival
Overall response rate
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Vactosertib + PomalidomideExperimental Treatment2 Interventions
Vactosertib tablets, taken once daily for the first and second dose levels and twice a day for third and fourth dose level levels for 5 days followed by 2 days without treatment, repeated for 28-day cycles until evidence of progressive disease, intolerable toxicity, or participant discontinuation.
For dose escalation - dosing initiated at 60 mg once daily by oral administration and will be increased to determine MTD. Provisional subsequent doses are 60, 120, once daily and 100 mg and 200 mg twice daily on days 1-5, 8-12, 15-19 and 22-26. Extension cohorts will enter at 200 mg twice daily (i.e. if MTD not defined) for 12 months until progression or intolerable toxicity.
POM is administered orally (4 mg/day daily on Days 1 - 21 days). Treatment will occur in a suitable outpatient ambulatory care setting that is equipped for monitoring of patients with hematopoietic malignancies undergoing early clinical trial research.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
Koen van BesienLead Sponsor
1 Previous Clinical Trials
1 Trials studying Multiple Myeloma
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,892 Total Patients Enrolled
26 Trials studying Multiple Myeloma
1,727 Patients Enrolled for Multiple Myeloma
Koen van Besien, MD, PhDPrincipal InvestigatorUniversity Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
6 Previous Clinical Trials
340 Total Patients Enrolled
1 Trials studying Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Criterion: You have plasma cell leukemia.Patients with a single plasmacytoma.You are not suitable for a specific type of stem cell transplant called autologous stem cell transplant.You have been treated with pomalidomide before.The patient is able to perform daily activities without needing much help.You have a disease that can be measured using specific criteria.You have certain medical conditions including HIV, Hepatitis B or C, heart problems, high blood pressure, lung disease, or severe allergic reactions to certain medications.You are taking medications that could interfere with the study drug.You cannot handle the medication to prevent blood clots.You have been diagnosed with multiple myeloma using standard criteria.You have a type of cancer that has come back or has not responded to treatment, and you have already been treated with a proteasome inhibitor and Immunomodulatory imide drugs.You must have evidence that your myeloma has gotten worse during or after your last treatment.You currently have cancer or have had cancer in the past that might affect the study results.You have had a bad reaction to a previous treatment that has not been resolved or is difficult to manage.You had a stem cell transplant with active graft versus host disease (GVHD) or took medicine to suppress your immune system in the past 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Vactosertib + Pomalidomide
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger