34 Participants Needed

Tasquinimod for Multiple Myeloma

HK
DV
Overseen ByDan Vogl, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is the first study of tasquinimod, an inhibitor of S100A9, in patients with multiple myeloma.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop all current medications, but you cannot have certain treatments like cytotoxic chemotherapy, proteasome inhibitors, Imids, monoclonal antibodies, or systemic corticosteroids shortly before starting the trial. You also cannot take drugs that are strong inhibitors or inducers of CYP3A4 or CYP1A2, or drugs with a narrow therapeutic range metabolized by these enzymes. Check with the trial team for specific guidance on your medications.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before starting the study. You must stop cytotoxic chemotherapy 3 weeks before, proteasome inhibitors, Imids, or monoclonal antibodies 2 weeks before, and systemic corticosteroids 7 days before the study. If you are on medications that affect CYP3A4 or CYP1A2 enzymes, you may need to stop those as well.

What safety data exists for Tasquinimod in treating multiple myeloma?

The provided research does not contain specific safety data for Tasquinimod in the treatment of multiple myeloma. The only mention of Tasquinimod is in a study related to castration-resistant prostate cancer, where it showed promising effects in inhibiting metastasis and delaying disease progression. No safety data for Tasquinimod in multiple myeloma is available in the given research.12345

What is known about the safety of Tasquinimod in humans?

Tasquinimod has been tested in a phase II clinical trial for prostate cancer, showing potential benefits in slowing disease progression, but specific safety data from this trial is not detailed in the available research.12345

Is the drug Tasquinimod a promising treatment for Multiple Myeloma?

Yes, Tasquinimod is a promising treatment for Multiple Myeloma. It works by targeting and reducing the activity of certain immune cells that help tumors grow, and it also stops the formation of new blood vessels that tumors need to grow. This makes it a potential new option for treating this type of cancer.16789

How is the drug Tasquinimod unique in treating multiple myeloma?

Tasquinimod is unique because it targets the tumor microenvironment by inhibiting the S100A9 protein, which helps reduce the immunosuppressive activity of myeloid cells and suppresses tumor growth. It also has anti-angiogenic effects, meaning it can prevent the formation of new blood vessels that tumors need to grow, making it a novel approach compared to traditional treatments.16789

What data supports the idea that Tasquinimod for Multiple Myeloma is an effective drug?

The available research does not provide specific data supporting the effectiveness of Tasquinimod for Multiple Myeloma. Instead, the studies focus on its use in treating prostate cancer, where it shows promise in slowing disease progression and inhibiting metastasis. For Multiple Myeloma, other drugs like immunomodulatory agents and proteasome inhibitors are highlighted as effective treatments, showing improved response rates and prolonged responses.1891011

What data supports the effectiveness of the drug Tasquinimod for treating multiple myeloma?

Tasquinimod has shown promise in treating prostate cancer by slowing disease progression and inhibiting metastasis (spread of cancer), which suggests it might have potential in treating other cancers like multiple myeloma. Its effects on the immune system and blood vessel growth in tumors could be beneficial in managing multiple myeloma.1891011

Who Is on the Research Team?

DV

Dan Vogl, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

For women of childbearing potential, a negative serum or urine pregnancy test prior to study treatment
I have been diagnosed with multiple myeloma.
I am not postmenopausal or surgically sterile and agree to use two forms of birth control.
See 7 more

Exclusion 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.
See 30 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Tasquinimod single agent dose escalation to establish maximum tolerated dose (MTD) and optimal schedule

Variable, up to 3 years

Combination Therapy

Tasquinimod in combination with ixazomib, lenalidomide, and dexamethasone to establish combination MTD and optimal schedule

Variable, up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tasquinimod
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: B2: Tasquinimod+IRd expansionExperimental Treatment2 Interventions
Group II: B1: Tasquinimod+IRd dose escalationExperimental Treatment2 Interventions
Group III: A2: Tasquinimod single agent expansionExperimental Treatment1 Intervention
Group IV: A1: Tasquinimod single agent dose escalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Active Biotech AB

Industry Sponsor

Trials
12
Recruited
2,200+

Published Research Related to This Trial

Tasquinimod has shown effectiveness in inhibiting the formation of metastases in castration-resistant prostate cancer, as demonstrated in both orthotopic and intratibial xenograft models.
The treatment appears to work by inducing molecular changes, such as upregulating thrombospondin 1 and downregulating hypoxia-driven genes, which contribute to its anti-angiogenic and anti-metastatic properties.
Inhibition of metastasis in a castration resistant prostate cancer model by the quinoline-3-carboxamide tasquinimod (ABR-215050).Jennbacken, K., Welén, K., Olsson, A., et al.[2017]
Novel agents like immunomodulatory drugs (IMiDs) and proteasome inhibitors (such as bortezomib) have significantly improved treatment outcomes for myeloma, showing better responses when used in combination with steroids and chemotherapy.
These therapies, initially used for relapsed or refractory myeloma, are now being tested in newly diagnosed patients, leading to higher response rates and longer-lasting effects.
Emerging therapies for multiple myeloma.Dingli, D., Rajkumar, SV.[2009]
Tasquinimod significantly suppresses the establishment and growth of prostate cancer tumors in the bone of castrated mice, indicating its potential as a treatment for metastatic prostate cancer.
The drug appears to work by altering the bone microenvironment, reducing immunosuppression, and affecting bone remodeling processes, which may help prevent new metastatic lesions from forming.
Tasquinimod inhibits prostate cancer growth in bone through alterations in the bone microenvironment.Magnusson, LU., Hagberg Thulin, M., Plas, P., et al.[2017]

Citations

Inhibition of metastasis in a castration resistant prostate cancer model by the quinoline-3-carboxamide tasquinimod (ABR-215050). [2017]
Emerging therapies for multiple myeloma. [2009]
Tasquinimod inhibits prostate cancer growth in bone through alterations in the bone microenvironment. [2017]
Tasquinimod (ABR-215050), a quinoline-3-carboxamide anti-angiogenic agent, modulates the expression of thrombospondin-1 in human prostate tumors. [2021]
Novel immunomodulatory compounds in multiple myeloma. [2018]
Risk of adverse events associated with front-line anti-myeloma treatment in Medicare patients with multiple myeloma. [2018]
Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. [2018]
Post-marketing safety of immunomodulatory drugs in multiple myeloma: A pharmacovigilance investigation based on the FDA adverse event reporting system. [2022]
Pomalidomide-dexamethasone in refractory multiple myeloma: long-term follow-up of a multi-cohort phase II clinical trial. [2019]
Tasquinimod suppresses tumor cell growth and bone resorption by targeting immunosuppressive myeloid cells and inhibiting c-MYC expression in multiple myeloma. [2023]
Mechanisms of action of tasquinimod on the tumour microenvironment. [2022]
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