Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy
Condition: Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma; Thrombocytopenia
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Thrombocytopenia
Intervention: romiplostim
Intervention description: Given SC
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well romiplostim works in increasing low platelet counts in
      patients with multiple myeloma receiving chemotherapy. Romiplostim may cause the body to make
      platelets after chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntary written informed 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             not part of normal medical care, with the understanding that consent may be withdrawn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

          -  Subject is not pregnant or breast feeding, and cannot become pregnant within 30 days
             after the end of treatment

          -  Female subject of child bearing potential must be willing to use, in combination with
             her partner, 2 forms highly effective contraception during treatment and for 1 month
             after the end of treatment

          -  Diagnosis of any stage of multiple myeloma based on standard criteria as follows:

               -  Major criteria

                    1. Plasmacytomas on tissue biopsy

                    2. Bone marrow plasmacytosis (> 30% plasma cells)

                    3. Monoclonal immunoglobulin spike on serum electrophoresis (immunoglobin G
                       [IgG] > 3.5 G/dL or immunoglobin A [IgA] > 2.0 G/dL) or kappa or lambda
                       light chain excretion > 1 G/day on 24 hour urine protein electrophoresis

               -  Minor criteria

                    1. Bone marrow plasmacytosis (10 to 30% plasma cells)

                    2. Monoclonal immunoglobulin present but of lesser magnitude than given under
                       major criteria

                    3. Lytic bone lesions

                    4. Normal immunoglobin M (IgM) < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

               -  Any of the following sets of criteria will confirm the diagnosis of multiple
                  myeloma:

                    -  Any two of the major criteria

                    -  Major criterion 1 plus minor criterion b, c, or d

                    -  Major criterion 3 plus minor criterion a or c

                    -  Minor criteria a, b and c or a, b and d

          -  Karnofsky performance status >= 50

          -  Platelet count =< 50 x 10^9/L untransfused of at least 2 weeks duration, secondary to
             prior chemotherapy. If there is a platelet count of > or = 50 x 10(9)/L after a
             transfusion, that value will be discounted.

        This may include a combination regimen including lenalidomide; these regimens will include
        dexamethasone, cyclophosphamide, etoposide, cisplatin (DCEP), Velcade with Doxil, Cytoxan
        and/or lenalidomide; patients who have thrombocytopenia (CIT) from lenalidomide or from
        radiation therapy alone will not be allowed

          -  Calculated or measured creatinine clearance >= 30 mL/min

        Exclusion Criteria:

          -  POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
             endocrinopathy, monoclonal protein [M-protein] and skin changes)

          -  Plasma cell leukemia

          -  Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus
             erythematosus, rheumatoid arthritis

          -  Infection not controlled by antibiotics

          -  Human immunodeficiency virus (HIV) infection; patients should provide consent for HIV
             testing according to the institution's standard practice

          -  Known active hepatitis B or C

          -  Patient had myocardial infarction within 6 months prior to enrollment, New York
             Hospital 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

          -  Diagnosed or treated for another malignancy within 3 years of enrollment, with the
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
             the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy

          -  Other serious medical or psychiatric illness that could potentially interfere with the
             completion of treatment according to this protocol

          -  Female subject is pregnant or lactating; confirmation that the subject is not pregnant
             must be established by a negative serum beta-human chorionic gonadotropin (hCG)
             pregnancy test result obtained during screening; pregnancy testing is not required for
             postmenopausal or surgically sterilized women

          -  Patient has > 1.5 x upper limit of normal (ULN) total bilirubin

          -  Patients with existing deep venous thrombosis will be excluded

          -  Patients receiving maintenance therapy with myelosuppressive medications such as
             lenalidomide will be excluded