Continuous Versus Intermittent Dosing Regimens for Pomalidomide in Relapsed/Refractory Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

Lenalidomide has clinical activity in myeloma. The closely related compound, Pomalidomide, may have clinical activity in patients who have previously been treated with lenalidomide and who no longer respond to it. The mechanism of anti-tumor effects of these drugs has been attributed to several effects including anti-angiogenesis, immune activation, and anti-proliferative effects. Recent studies have suggested that these agents can mediate surprisingly rapid biologic effects on human monocytes and T cells. Our hypothesis is that the proximate effects of these drugs will be sensitive and quantitative surrogates of subsequent effects including activation of tumor antigen specific T cells as well as innate immune cells. Understanding the correlation between the pharmacodynamics of these effects with downstream activation using quantitative assays will facilitate the rational development of pomalidomide as immune-modulatory drug in diverse settings as well as its optimal development in myeloma therapy.

Key facts

Study ID

NCT01319422

Run by

Yale University

People needed

40

Starts

2011-06-01

Expected to finish

2014-11-01

Last updated by the study team

2016-08-11

Who can join

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

You may qualify if…

• Understand and voluntarily sign an informed consent form.
• Age ≥18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Relapsed / Refractory Multiple Myeloma following at least two prior standard therapies including lenalidomide. Induction therapy followed by autologous stem cell transplantation (ASCT) is considered one regimen.
• Patients must be refractory to prior lenalidomide therapy. For the purpose of this protocol, refractory will be defined as history of progression on a regimen containing full or maximally tolerated dose of lenalidomide administered for a minimum of at least one complete cycle of therapy.
• All patients must have measurable disease defined as one or more of the following criteria:
• Serum monoclonal protein greater than 10 g/L, serum immunoglobulin free light chain (FLC) more than 10 mg/dL and an abnormal FLC ratio, urine light-chain excretion > 200 mg/24 h, measurable soft tissue plasmacytoma that has not been irradiated, or greater than 30% plasma cells in bone marrow.
• All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
• Eastern Cooperative Oncology Group (ECOG ) performance status of ≤ 2 at study entry (see Appendix D).
• Laboratory test results within these ranges:
• Absolute neutrophil count ≥ 1.0 x 1000/microliter (uL)
• Platelet count ≥ 75 x 1000/uL
• Serum creatinine ≤ 2.5 mg/dL
• Total bilirubin ≤ 2 mg/dL
• aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 5 x upper limit of normal (ULN)
• Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
• Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 milli-international unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A and B: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Education and Counseling Guidance Document.
• Able to take aspirin (ASA) (81 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

You may not qualify if…

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking pomalidomide).
• Women of child-bearing potential who are unwilling to use a dual method of contraception; and men who are unwilling to use a condom.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide or lenalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, pomalidomide or similar drugs.
• Any prior use of pomalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or active infectious hepatitis, B or C.
• Grade 3 or 4 peripheral neuropathy

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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