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Status:

COMPLETED

Samarium 153 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Lead Sponsor:

Oncotherapeutics

Conditions:

Multiple Myeloma and Plasma Cell Neoplasm

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Radioactive substances, such as samarium 153, may release radiation as it breaks down and kill cancer cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes n...

Detailed Description

OBJECTIVES: Primary * Assess the safety and tolerability (maximum tolerated dose and dose-limiting toxicity) of samarium Sm 153 lexidronam pentasodium and bortezomib in patients with relapsed or ref...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosed with multiple myeloma by 1 of the following criteria:
  • Meets any 2 of the following major criteria:
  • Plasmacytomas on tissue biopsy
  • Bone marrow plasmacytosis (i.e., \> 30% plasma cells)
  • Monoclonal immunoglobulin spike IgG \> 3.5 g/dL or IgA \> 2.0 g/dL by serum electrophoresis; kappa or lambda light chain excretion \> 1 g by 24-hour urine protein electrophoresis
  • Plasmacytomas on tissue biopsy AND meets any 1 of the following minor criteria:
  • Presence of monoclonal immunoglobulin at a lesser magnitude than given under above major criteria
  • Lytic bone lesions
  • Normal IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
  • Monoclonal immunoglobulin spike IgG \> 3.5 g/dL or IgA \> 2.0 g/dL by serum electrophoresis; kappa or lambda light chain excretion \> 1 g by 24-hour urine protein electrophoresis AND meets 1 of the following minor criteria:
  • Bone marrow plasmacytosis (i.e., 10-30% plasma cells)
  • Lytic bone lesions
  • Presence of monoclonal immunoglobulin at a lesser magnitude than given under major criteria with bone marrow plasmacytosis (i.e., 10-30% plasma cells) AND meets 1 of the following minor criteria:
  • Lytic bone lesions
  • Normal IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL
  • Measurable disease, defined as a monoclonal immunoglobulin spike of ≥ 1 gm/dL by serum electrophoresis and/or a immunoglobulin spike of ≥ 200 mg by 24-hour urine protein electrophoresis or evidence of lytic bone disease OR
  • Nonmeasurable disease (i.e., patients with nonsecretory or oligosecretory multiple myeloma)
  • Relapsed or refractory disease
  • Relapsed disease following a response or stable disease after prior chemotherapy (e.g., single-agent steroids, vincristine, doxorubicin, and dexamethasone \[VAD\], or melphalan and prednisone \[MP\]) or high-dose chemotherapy
  • Refractory (i.e., failure to achieve at least complete or partial response or stable disease) to the most recent chemotherapy with or without systemic corticosteroids
  • No plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein), and skin changes (POEMS syndrome)
  • No extramedullary myeloma
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 60-100%
  • Life expectancy \> 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN (unless clearly related to disease)
  • Creatinine clearance ≥ 30 mL/min
  • Creatinine clearance \> 15 mL/min and \< 30 mL/min due to significant myelomatous involvement of kidneys allowed at discretion of investigator
  • Sodium \> 130 mmol/L
  • No ECG evidence of acute ischemia or new conduction system abnormalities
  • No myocardial infarction within the past 6 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL)
  • No New York Hospital Association class III or IV heart failure
  • No poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that would preclude study treatment
  • No known HIV history
  • No known active hepatitis B or C viral infection
  • No history of allergic reaction attributable to compounds of similar chemical or biological composition to bortezomib, boron, mannitol, ethylenediaminetetramethylenephosphonic acid (EDTMP), or phosphonates
  • No peripheral neuropathy \> grade 1
  • PRIOR CONCURRENT THERAPY:
  • At least 12 weeks since prior samarium Sm 153 lexidronam pentasodium
  • No more than 1 prior treatment
  • At least 24 weeks since prior strontium chloride Sr 89
  • No more than 1 prior treatment
  • No major surgery within the past 4 weeks
  • No chemotherapy within the past 3 weeks (6 weeks for nitrosoureas)
  • No corticosteroids (\> 10 mg/day prednisone or equivalent) within the past 3 weeks
  • No immunotherapy, antibody therapy, or radiotherapy (except localized radiotherapy) within the past 4 weeks
  • No other concurrent investigational agents
  • No concurrent corticosteroids (≥ 10 mg prednisone or equivalent)

Exclusion

    Key Trial Info

    Start Date :

    December 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 1 2011

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT00316940

    Start Date

    December 1 2005

    End Date

    February 1 2011

    Last Update

    September 20 2013

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Comprehensive Blood and Cancer Center

    Bakersfield, California, United States, 93309-0633

    2

    Hematology-Oncology Medical Group of Fresno, Incorporated

    Fresno, California, United States, 93720

    3

    West Hollywood, California, United States, 90069

    4

    Center for Cancer and Blood Disorders at Suburban Hospital

    Bethesda, Maryland, United States, 20817