Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: dexamethasone; clarithromycin; Pomalidomide
Intervention description: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle; orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle; orally 4mg daily for days 1-21 of each 28 day cycle
Intervention MeSH terms: Clarithromycin; Dexamethasone; Pomalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is intended to investigate the combination of the combination of dexamethasone
      (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) [ClaPd] in multiple
      myeloma patients who have relapsed or refractory disease who have failed prior treatment with
      lenalidomide when used alone or in combination with corticosteroids. Primary endpoint will be
      response rate to treatment. Secondary endpoints will include toxicity of the combination,
      time to maximum response, and time to disease progression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must voluntarily sign and understand written informed consent.

          -  Age > 18 years at the time of signing the consent form.

          -  Histologically confirmed MM

          -  Relapsed or refractory myeloma, progression of disease either after prior therapy or
             lack of response to currently used therapy.

          -  Relapsed or progressive disease after at least 3 prior therapeutic treatments or
             regimens for multiple myeloma.

          -  Must have been previously treated with lenalidomide and has been determined to be
             refractory, resistant, or relapsed.

          -  Measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum
             free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable
             plasmacytoma(s).

          -  Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma

          -  Females of childbearing potential (FCBP)† must have a negative serum or urine
             pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
             and again within 24 hours of prescribing lenalidomide and thalidomide (prescriptions
             must be filled within 7 days) 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 4
             weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy
             testing. Men must agree to use a latex condom during sexual contact with females of
             child bearing potential even if they have had a successful vasectomy. See Appendix V:
             Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable
             Birth Control Methods. †A female of childbearing potential is a sexually mature woman
             who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
             naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at
             any time in the preceding 24 consecutive months).

          -  Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA
             may use warfarin or low molecular weight heparin). †

          -  1ife expectancy ≥ 3 months

          -  Subjects must meet the following laboratory parameters:

        Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Platelets count ≥ 50,000/mm3
        (75 x 109/L) Serum SGOT/AST ≤ 2.0 x upper limits of normal Serum SGPT/ALT <3.0 x upper
        limits of normal (ULN) Serum creatinine ≤ 2.5 x upper limits of normal Serum total
        bilirubin ≤ 1.5 x upper limits of normal

        Exclusion Criteria:

          -  Patients with non-secretory MM (no measurable monoclonal protein, free light chains,
             and/or M-spike in blood or urine).

          -  Prior history of other malignancies (except for basal cell or squamous cell carcinoma
             of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5
             years.

          -  Myocardial infarction within 6 months prior to enrollment, or NYHA(New York Hospital
             Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled
             ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active
             conduction system abnormalities.

          -  Known HIV infection

          -  Known hepatitis B or hepatitis C infection.

          -  Active viral or bacterial infections or any coexisting medical problem that would
             significantly increase the risks of this treatment program.

          -  Any coexisting medical problem or laboratory evaluation that, in the treating
             physician's or principal investigator's opinion, makes the patient unsuitable to
             participate in this clinical trial.

          -  Known hypersensitivity to thalidomide or lenalidomide.

          -  History of thromboembolic event within the past 6 months prior to enrollment.

          -  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.

          -  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 14 days of baseline.

          -  Known hypersensitivity to thalidomide or lenalidomide.

          -  The development of erythema nodorum if characterized by a desquamating rash while
             taking thalidomide, CC-4047 or similar drugs.

          -  Any prior use of CC-4047.

          -  Concurrent use of other anti-cancer agents or treatments.