Status:
TERMINATED
Tasquinimod for the Treatment of Relapsed or Refractory Myeloma
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Active Biotech AB
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is the first study of tasquinimod, an inhibitor of S100A9, in patients with multiple myeloma.
Detailed Description
Tasquinimod has previously been studied as an anti-cancer agent in patients with other cancers, including a phase 3 randomized trial in patients with metastatic prostate cancer that showed an improvem...
Eligibility Criteria
Inclusion
- Signed informed consent
- 18 years of age or older
- Multiple myeloma (MM) diagnosed according to IMWG criteria
- Measurable disease (this is defined differently in different arms)
- Multiple myeloma relapsed or refractory to treatment (this is defined differently in different arms)
- Meet certain clinical laboratory criteria
- ECOG performance status ≤2
- Life expectancy of at least 3 months
- For women of childbearing potential, a negative serum or urine pregnancy test prior to study treatment.
- For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two methods of contraception one of which must be highly effective
- For men: agreement to use a barrier method of contraception for 1 month before start of study treatment, during the treatment period and for 6 months after the last dose of study treatment.
Exclusion
- Failure to have fully recovered (i.e. ≤ Grade 1 toxicity) from the effects of prior chemotherapy (except for alopecia)
- Active graft versus host disease
- Treatment with any of the following:
- Cytotoxic chemotherapy within 3 weeks prior to the initiation of study treatment
- Proteasome inhibitors, Imids, or monoclonal antibodies within 2 weeks prior to the initiation of study treatment
- Experimental therapy within 4 weeks or 5 half-lives, whichever is shorter
- Systemic corticosteroids \>=10 mg prednisone or equivalent within 7 days prior to the initiation of study treatment
- Radiotherapy within 7 days prior to initiating study treatment
- Plasmapheresis within 4 weeks prior to the initiation of study treatment
- Tasquinimod at any time
- Known central nervous system involvement by myeloma
- Diagnosis of smoldering multiple myeloma
- Diagnosis of POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Active plasma cell leukemia
- Symptomatic primary (AL) amyloidosis
- Diagnosis of myelodysplastic syndrome or myeloproliferative syndrome
- Active other malignancy
- Major surgery within 4 weeks prior to initiating study treatment
- Evidence of severe or currently uncontrolled cardiovascular condition
- Ongoing or active systemic infection that requires systemic antibiotic or parenteral anti-infective therapy
- Active tuberculosis, active hepatitis A, B or C virus infection, or known human immunodeficiency virus (HIV) positive
- History of pancreatitis
- History of malabsorption or other condition that would interfere with absorption of study drugs
- Systemic treatment within 14 days prior to the initiation of study treatment with moderate or strong inhibitor or moderate or strong inducer of cytochrome P-3A4 (CYP3A4)
- Need for ongoing therapy drug substances of narrow therapeutic range that are metabolized mainly by CYP3A4 (alfentanil, fentanyl, quinidine, astemizole, terfenadine, sirolimus, tacrolimus, cyclosporine, cisapride, ergotamine)
- Need for ongoing therapy with drug substances of narrow therapeutic range metabolized mainly by CYP1A2 (duloxetine, alosetron, theophylline, tizanidine, ondansetron)
- Ongoing treatment with warfarin, unless the INR is \<=3.0.
- For subjects enrolled on the IRd combination arms, prior dose-limiting toxicity with lenalidomide or ixazomib or absolute contraindication to concomitant thrombosis prophylaxis
- Peripheral neuropathy grade ≥2 (NCI-CTCAE)
- Known hypersensitivity to tasquinimod or any excipients in the study treatments
- Pregnant or nursing (lactating) women
- Any other condition that would, in the Investigator's judgment, contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures
- Prior inclusion in this study
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04405167
Start Date
July 10 2020
End Date
July 1 2025
Last Update
October 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104