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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 below
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I have been diagnosed with multiple myeloma.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

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 more

Trial 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
2,002 Previous Clinical Trials
42,880,965 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

Tasquinimod (S100A9 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04405167 — Phase 1
Multiple Myeloma Research Study Groups: B1: Tasquinimod+IRd dose escalation, A2: Tasquinimod single agent expansion, A1: Tasquinimod single agent dose escalation, B2: Tasquinimod+IRd expansion
Multiple Myeloma Clinical Trial 2023: Tasquinimod Highlights & Side Effects. Trial Name: NCT04405167 — Phase 1
Tasquinimod (S100A9 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04405167 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has Tasquinimod been studied prior to now?

"Currently, Tasquinimod is the subject of 715 clinical studies. Of those, 168 are in Phase 3 and a significant number originate from Joliet, Illinois; though this drug is being trialled across 26000 sites globally."

Answered by AI

What afflictions has Tasquinimod been prescribed to address?

"Tasquinimod is traditionally administered to people with ophthalmia, sympathetic. This medication can also be prescribed for branch retinal vein occlusion and macular edema in patients who had prior systemic chemotherapy regimens."

Answered by AI

What risks have been associated with Tasquinimod treatment?

"Considering the limited data surrounding Tasquinimod's safety and efficacy, our team at Power rated it a 1 on their scale."

Answered by AI

What is the current enrollment rate of this clinical investigation?

"Affirmative. All the information available on clinicaltrials.gov suggests this research is presently in need of participants. This venture was initially published July 10th 2020 and last updated November 21st 2022, with a total of 34 patients being accepted at 1 location."

Answered by AI

Is it still feasible to register for this research endeavor?

"Affirmative. According to the info posted on clinicaltrials.gov, this investigation is still open for enrolment and commenced on July 10th 2020. The last update was November 21st 2022, seeking a total of 34 participants from one centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tasquinimod for the Treatment of Relapsed or Refractory Myeloma
2020. "Tasquinimod for the Treatment of Relapsed or Refractory Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04405167.
~1 spots leftby Jul 2024
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