Open-label Study of TH-302 and Dexamethasone With or Without Bortezomib or Pomalidomide in Subjects With Relapsed/Refractory Multiple Myeloma

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

This phase 2 study is designed to evaluate the safety and tolerability activity of TH-302 and dexamethasone with or without bortezomib or pomalidomide in subjects with relapsed/refractory multiple myeloma.

Key facts

Study ID

NCT01522872

Run by

Threshold Pharmaceuticals

People needed

98

Starts

2012-02-01

Expected to finish

2017-09-01

Last updated by the study team

2016-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age.
• Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee.
• Relapsed/refractory multiple myeloma for which no standard therapy options are anticipated to result in a durable remission.
• Receipt of at least two prior therapies as indicated by protocol
• Subjects with measurable disease
• ECOG performance status of less than or equal to 2
• Acceptable liver function
• Acceptable renal function
• Acceptable hematologic status
• For Part A, B, C subjects: Women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception with their partner as indicated by protocol For Part D subjects: a negative serum pregnancy test is required within 10- 14 days prior to initiating with pomalidomide, AND a negative serum pregnancy test within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control at least 28 days before she starts taking pomalidomide.
• Women of childbearing potential must enroll into and follow all requirements of the POMALYST REMS program, which includes adhering to the scheduled pregnancy testing.
• Men must agree to use a latex or synthetic condom during sexual contact with women of child bearing potential even if they have had a vasectomy.
• All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure, or when a female patient misses her period or if there is any abnormality in her menstrual bleeding.
• Subjects must adhere to the study visit schedule and other protocol requirements and receive outpatient therapy and laboratory monitoring at the institute that administers the study drug.

You may not qualify if…

• Subjects who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes.)
• Waldenstrom's macroglobulinemia
• Localized radiation therapy to only measurable disease site(s) within 2 weeks of treatment
• New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 6 months prior to Day 1, or unstable arrhythmia
• Significant neuropathy (Grade 3 or 4, or Grade 2 with pain) at the time of enrollment or within 14 days before enrollment
• Symptomatic brain metastases (unless previously treated and well controlled for a period of ≥ 3 months)
• Severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia
• Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 14 days prior to the first dose
• Previously treated malignancies, except for adequately treated non-melanoma skin cancer (basal cell or squamous cell), in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
• Subjects who participated in an investigational drug or device study within 2 weeks prior to study entry
• Known or suspected active infection with HIV, hepatitis A, hepatitis B, or hepatitis C
• Subjects who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation similar to TH-302, bortezomib (for subjects enrolled in Part C only), pomalidomide (Part D), dexamethasone or pimonidazole
• Females who are pregnant or breast-feeding
• Concomitant psychiatric disease or medical condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
• Unwillingness or inability to comply with the study protocol for any reason
• Previous cytotoxic therapies for multiple myeloma within 3 weeks prior to study entry (2 weeks for biologic, novel therapy or corticosteroids)
• Subjects who have been on hormone replacement less than 2 months (subjects on hormone replacement for at least 2 months will not be excluded provided the HRT regimen remains unchanged during the conduct of the study).
• Prior peripheral stem cell transplant within 12 weeks of the start of study
• Epilepsy or other convulsive disorder requiring active management
• Prior therapy with a pomalidomide-containing regimen
• Subjects on strong inducers or strong inhibitors of cytochrome P450 CYP3A4 or CYP1A2
• Any other medical condition that in opinion of investigator would place patient at increased risk for toxicity during pomalidomide treatment (i.e. history of recurrent or serious thromboembolic events)

Where it is running

• Pacific Cancer Care — Monterey, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Maine Center for Cancer Medicine — Scarborough, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• The West Clinic — Southaven, Mississippi, United States
• New York Oncology Hematology — Albany, New York, United States
• New York Oncology Hematology — Hudson, New York, United States
• The West Clinic — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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