Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Condition: Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: dinaciclib; laboratory biomarker analysis
Intervention description: Given IV; Correlative studies
Intervention MeSH terms: Cyclin-Dependent Kinase Inhibitor Proteins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving dinaciclib works in treating patients with
      relapsed or refractory multiple myeloma. Dinaciclib may stop the growth of cancer cells by
      clocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed or refractory multiple myeloma

          -  Measurable disease as defined by at least ONE of the following:

               -  Serum monoclonal protein >= 1.0 g/dL

               -  > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

               -  Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum
                  immunoglobulin kappa to lambda free light chain ratio

          -  ≤ 5 prior therapies; stem cell transplantation and preceding induction therapy will be
             considered as one therapy; NOTE: Patients must not be candidates for stem cell
             transplantation or should have had stem cells collected previously

          -  Life expectancy of ≥ 3 months

          -  ECOG performance status of 0, 1 or 2

          -  Absolute neutrophil count >= 1,000/mcL

          -  Platelets >= 75,000/mcL

          -  Hemoglobin >= 8 g/dL

          -  Total serum bilirubin within normal institutional limits

          -  AST (SGOT)/ALT(SGPT) =< 2.5 X institutional ULN

          -  Creatinine < 2.5 mg/dL

          -  Negative serum pregnancy test done ≤7 days prior to registration (for women of
             childbearing potential only); NOTE: Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willingness to provide blood and bone marrow samples for mandatory research component
             of this study; (US sites only)

        Exclusion Criteria:

          -  Any of the following prior therapies:

               -  Myelosuppressive therapy for myeloma ≤ 3 weeks prior to registration or those who
                  have not recovered from acute reversible adverse events due to agents
                  administered > 3 weeks earlier

               -  Non-myelosuppressive agents like thalidomide or high dose corticosteroids ≤ 2
                  weeks prior to registration

          -  Receiving any other investigational agents

          -  Concomitant high dose corticosteroids

               -  NOTE: Concurrent use of corticosteroids, but patients may be on chronic steroids
                  (maximum dose 20 mg/day prednisone equivalent) if they are being given for
                  disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis,
                  etc.

               -  NOTE: Bisphosphonates are considered to be supportive care rather than therapy,
                  and are thus allowed while on protocol treatment

          -  Active malignancy with the exception of non melanoma skin cancer or in situ cervical
             or breast cancer

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infections or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant or nursing women; NOTE: Because there is an unknown but potential risk for
             adverse events in nursing infants secondary to treatment of the mother with SCH
             727965, breastfeeding should be discontinued if the mother is treated with SCH 727965

          -  Currently taking inhibitors/inducers of CYP3A4; (SCH 727965 metabolizes via the CYP3A4
             enzyme; there are potential drug interactions with concomitant use of CYP3A4 potent
             inhibitors/inducers; Principal Investigator should review each case and determine if
             patients on the CYP3A4 potent inhibitors/inducers are eligible and will make all
             effort to switch to alternative drugs; patients should not take grapefruit/ grapefruit
             juice or St. Johns' Wort)

          -  Men or women of childbearing potential who are unwilling to employ adequate
             contraception