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S100A9 Inhibitor
Tasquinimod for Multiple Myeloma
Phase 1
Recruiting
Led By Dan Vogl, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Multiple myeloma (MM) diagnosed according to IMWG criteria
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights
Study Summary
This trial is testing a new drug, tasquinimod, to see if it can help treat multiple myeloma.
Who is the study for?
Adults diagnosed with relapsed or refractory multiple myeloma, who have measurable disease and are in relatively good health (ECOG ≤2), can join this trial. They must not be pregnant, agree to use contraception, and meet specific lab criteria. Exclusions include recent chemotherapy, certain medical conditions like active infections or severe cardiovascular issues, known allergies to study drugs, and prior treatment with tasquinimod.Check my eligibility
What is being tested?
The trial is testing a new drug called tasquinimod for multiple myeloma that has come back or didn't respond to treatment. It's being compared with IRd chemotherapy regimen. Tasquinimod inhibits S100A9 which could help control the progression of cancer.See study design
What are the potential side effects?
Tasquinimod may cause side effects such as fatigue, digestive problems, potential blood disorders, and possibly affect organ function due to its mechanism of action. The exact side effects will be studied as part of the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma.
Select...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Optimal Dose
Secondary outcome measures
Preliminary Assessment of Clinical Response Combination Therapy
Preliminary Combination Therapy Toxicity Profile
Preliminary Single-Agent Response
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: B2: Tasquinimod+IRd expansionExperimental Treatment2 Interventions
Additional subjects will enroll in arm B2 at the MTD and optimal schedule, so that 12 subjects total who are both evaluable for response and previously refractory to their most recent Imid/PI combination will have received the MTD/optimal schedule of tasquinimod in combination with ixazomib, lenalidomide, and dexamethasone. To facilitate rapid enrollment and gain more experience with the combination therapy, up to 12 additional subjects with triple-class refractory myeloma (who are not previously refractory to their most recent Imid/PI combination) may be enrolled in cohort B2. Enrollment in arm B2 will not begin until enrollment in arm B1 has been completed and a combination MTD/optimal schedule has been established.
Group II: B1: Tasquinimod+IRd dose escalationExperimental Treatment2 Interventions
Dose levels will be defined according to the same tasquinimod doses as in the single agent (Arm A1) dose escalation. Enrollment in arm B1 will not begin until enrollment in arm A1 has been completed and an MTD/optimal schedule has been established for single agent tasquinimod. Initial subjects in arm B1 will be enrolled at the lower of dose level 1 or one dose level below the single agent MTD . If this initial dose level is determined to exceed the combination MTD, further subjects will be enrolled at one dose level lower. Enrollment is not planned in arm B1 at doses higher than the single agent MTD. There are 9-12 planned subjects if all dose levels are explored.
Group III: A2: Tasquinimod single agent expansionExperimental Treatment1 Intervention
Additional subjects will enroll in arm A2 at the MTD and optimal schedule, so that 12 subjects total who are evaluable for response will have received the MTD/optimal schedule of single agent tasquinimod. Enrollment in arm A2 will not begin until enrollment in arm A1 has been completed and a single agent MTD/optimal schedule has been established.
Group IV: A1: Tasquinimod single agent dose escalationExperimental Treatment1 Intervention
There are up to 5 planned dose levels, with 3 de-escalation dose levels available in case dose level 1 is determined to exceed the MTD. This arm will enroll 15-30 subjects if all dose levels are explored.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tasquinimod
2012
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
Active Biotech ABIndustry Sponsor
11 Previous Clinical Trials
2,151 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,018 Previous Clinical Trials
42,874,098 Total Patients Enrolled
13 Trials studying Multiple Myeloma
345 Patients Enrolled for Multiple Myeloma
Dan Vogl, MDPrincipal InvestigatorUniversity of Pennsylvania
4 Previous Clinical Trials
192 Total Patients Enrolled
3 Trials studying Multiple Myeloma
42 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing treatment.I do not have active tuberculosis, hepatitis A, B, C, or HIV.I am currently on antibiotics or IV medication for an infection.I have been diagnosed with multiple myeloma.I have had pancreatitis before.I need continuous medication that is sensitive and processed by a specific part of my liver.My myeloma has spread to my brain or spinal cord.I do not have moderate or severe numbness, tingling, or pain in my hands or feet.I haven't taken proteasome inhibitors, Imids, or monoclonal antibodies in the last 2 weeks.I have symptoms caused by AL amyloidosis.I have another active cancer besides the one being treated.I am on warfarin with an INR of 3.0 or less.I have active plasma cell leukemia.I am not postmenopausal or surgically sterile and agree to use two forms of birth control.I haven't taken strong medication affecting liver enzymes in the last 2 weeks.I had severe side effects with lenalidomide or ixazomib, or I cannot take blood clot prevention medication.I have a serious heart condition that is not under control.I am 18 years old or older.My multiple myeloma has returned or didn't respond to treatment.You are expected to live for at least 3 months.I have been diagnosed with POEMS syndrome.You need to meet specific requirements for your medical test results.I have been diagnosed with smoldering multiple myeloma.I can take care of myself but might not be able to do heavy physical work.I have been diagnosed with a bone marrow disorder.I have not had major surgery in the last 4 weeks.Your disease can be measured to see how it changes during the study.I agree to use barrier contraception from 1 month before until 6 months after treatment.I haven't had any experimental treatments in the last 4 weeks or 5 half-lives, whichever is shorter.I have a condition that affects how my body absorbs medication.I have not undergone plasmapheresis in the last 4 weeks.I need continuous medication that is sensitive and processed by a specific part of my liver.I have not had radiotherapy in the week before starting the study treatment.You are currently experiencing graft versus host disease.I haven't had chemotherapy in the last 3 weeks.I have recovered from previous chemotherapy side effects, except for hair loss.I have never taken Tasquinimod.I haven't taken high doses of steroids in the week before starting the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: B1: Tasquinimod+IRd dose escalation
- Group 2: A2: Tasquinimod single agent expansion
- Group 3: A1: Tasquinimod single agent dose escalation
- Group 4: B2: Tasquinimod+IRd expansion
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.
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