Multiple Myeloma Clinical Trial
Tasquinimod for the Treatment of Relapsed or Refractory Myeloma
This study is the first study of tasquinimod, an inhibitor of S100A9, in patients with multiple myeloma.
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 improvement in radiographic progression-free survival. The side effect profile of tasquinimod is well-characterized based on this previous experience. This trial will establish a maximum tolerated dose and optimal schedule for administration of tasquinimod in patients with multiple myeloma and then investigate the maximum tolerated dose of tasquinimod in combination with a standard myeloma regimen of ixazomib, lenalidomide, and dexamethasone (IRd). For both single agent tasquinimod and the combination of tasquinimod with IRd, exploratory expansion cohorts will be enrolled to preliminarily characterize the antimyeloma activity of each regimen.
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.
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
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