Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant
Condition: Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: bortezomib; cyclophosphamide; lenalidomide; laboratory biomarker analysis; dexamethasone; quality-of-life assessment
Intervention description: Given SC; Given PO; Given PO; Correlative studies; Given PO; Ancillary studies
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Lenalidomide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Maintenance; Consolidation

Summary:

      This randomized phase II trial studies how well giving bortezomib with or without combination
      chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma
      who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by
      blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as
      cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth
      of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet
      known whether giving bortezomib is more effective with or without combination chemotherapy in
      the post transplant setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Creatinine =< 2 mg/dL

          -  Absolute neutrophil count (ANC) >= 1000/mm^3

          -  Platelet count >= 75000/mm^3

          -  Hemoglobin >= 8.0 g/dL

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Treated myeloma: Prior induction therapy (any) and followed by autologous stem cell
             transplantation

          -  Measurable disease at initial diagnosis, pre-stem cell transplant (SCT) or post-SCT of
             multiple myeloma as defined by at least ONE of the following:

               -  Serum monoclonal protein >= 0.5 g/dL

               -  > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

               -  Serum immunoglobulin free light chain >= 5 mg/dL AND abnormal serum
                  immunoglobulin kappa to lambda free light chain ratio

               -  Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

          -  < 120 days post SCT with no evidence of relapse or progression prior to registration

          -  Provide voluntary informed written consent before performance of any study-related
             procedure not part of normal medical care, with the understanding that consent may be
             withdrawn by the subject at any time without prejudice to future medical care

          -  Negative serum pregnancy test done =< 7 days prior to registration, for women of
             childbearing potential only

          -  Willing to return to enrolling institution for follow-up during the active monitoring
             phase of the study

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Female patients who:

               -  Are postmenopausal for at least 1 year before the screening visit, OR

               -  Are surgically sterile, OR

               -  If they are of childbearing potential, agree to practice 2 effective methods of
                  contraception, at the same time, from the time of signing the informed consent
                  through 30 days after the last dose of study treatment, OR agree to completely
                  abstain from heterosexual intercourse

          -  Male patients, even if surgically sterilized (ie, status postvasectomy), who:

               -  Agree to practice effective barrier contraception during the entire study
                  treatment period and through 30 days after the last dose of study treatment, OR

               -  Agree to completely abstain from heterosexual intercourse

        Exclusion Criteria:

          -  Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic
             skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history of prior
             malignancy, they must not be receiving other specific treatment for their cancer

          -  Other co-morbidity which would interfere with patient's ability to participate in
             trial, e.g. uncontrolled infection, uncompensated heart or lung disease

          -  Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered
             investigational; NOTE: Bisphosphonates are considered to be supportive care rather
             than therapy, and are thus allowed while on protocol treatment

          -  Known to be human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B
             virus positive (HBV+)

          -  Hypersensitivity to study drugs, boron or mannitol

          -  Patient refractory to bortezomib (defined as patients who progressed while on
             bortezomib or within 60 days of receiving bortezomib)

          -  Any serious medical or psychiatric condition that would prevent the subject from
             complying with the protocol treatment and procedures

          -  Grade >= 2 peripheral neuropathy

          -  Myocardial infarction within 6 months prior to enrollment or has New York Heart
             Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities; prior to study entry, any
             electrocardiogram (ECG) abnormality at screening must be documented by the
             investigator as not medically relevant

          -  Participation in clinical trials with other investigational agents not included in
             this trial, within 14 days of the start of this trial and throughout the duration of
             this trial

          -  Radiation therapy within 3 weeks before randomization; enrollment of subjects who
             require concurrent radiotherapy (which must be localized in its field size) should be
             deferred until the radiotherapy is completed and 3 weeks have elapsed since the last
             date of therapy

          -  Female patients who are lactating or pregnant