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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478075
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : May 11, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Brief Summary:

RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Bortezomib may also make cancer cells more sensitive to radiation therapy. Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in treating patients with relapsed or refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: bortezomib Other: immunologic technique Radiation: samarium Sm 153 lexidronam pentasodium Phase 1 Phase 2

Detailed Description:



  • Determine the maximum tolerated dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium in patients with recurrent or refractory multiple myeloma. (Phase I)
  • Determine the safety and tolerability of this regimen in these patients. (Phase II)
  • Determine the hematologic response rate in patients treated with this regimen. (Phase II)


  • Determine the rate of serum immunoglobulin light chain reduction in patients treated with this regimen.
  • Assess the in vivo toxicity of this regimen to the progenitor cells by measuring complete blood cell count and micronucleated reticulocyte count in these patients.

OUTLINE: This is a phase I, pilot, open-label, dose-escalation study of bortezomib followed by a phase II study.

  • Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1 and bortezomib IV over 3-5 seconds on days 2 and 5.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

  • Phase II: Patients receive samarium Sm 153 lexidronam pentasodium as in phase I and bortezomib at the MTD determined in phase I .

Patients undergo blood sample collection at baseline and then on days 1-6 for correlative studies. Samples are analyzed for micronucleated reticulocyte count and immunoglobulin free light chain ratio to determine the early effects of treatment.

After completion of study treatment, patients are followed weekly for 7 weeks, monthly for 3 months and then every 3 months for a total of 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of 153 Sm EDTMP (Quadramet™) and PS-341 (Velcade®) in Patients With Relapsed or Refractory Multiple Myeloma
Study Start Date : September 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : June 2009

Primary Outcome Measures :
  1. Toxicity (Phase I)
  2. Confirmed clinical response (complete response, very good partial response, partial response, or minimal response) (Phase II)

Secondary Outcome Measures :
  1. Immunoglobulin free light chain response
  2. Changes in complete blood cell count and micronucleated reticulocyte count

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of multiple myeloma

    • Relapsed or refractory disease
  • Measurable or evaluable disease as defined by at least 1 of the following:

    • Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
    • Monoclonal protein ≥ 200 mg by 24-hour urine electrophoresis
    • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
    • Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
  • Previously treated disease

    • No limit to prior therapy provided there is adequate residual organ function
  • Must have undergone hematopoietic stem cell collection (for transplant candidates) OR not considered to be a hematopoietic stem cell transplant candidate


  • ECOG performance status (PS) 0-2 (ECOG PS of 3 allowed if secondary only to pain)
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • ANC ≥ 1,000/mm^3
  • Creatinine ≤ 3 mg/dL
  • Calcium ≤ 15 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy
  • No impending long bone fracture
  • No other active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or breast cancer
  • No uncontrolled infection
  • No known hypersensitivity to any of the components of study drugs
  • No other co-morbidity that would preclude study participation


  • Recovered from prior surgery, radiotherapy, or other antineoplastic therapy
  • No prior samarium Sm 153 lexidronam pentasodium or strontium chloride Sr 89
  • At least 3 weeks since prior myelosuppressive agents
  • At least 2 weeks since prior nonmyelosuppressive agents (e.g., thalidomide)
  • At least 2 weeks since prior and no concurrent high-dose corticosteroids

    • Chronic steroids (maximum dose of 20 mg/day prednisone or equivalent) allowed for disorders other than myeloma (i.e., adrenal insufficiency or rheumatoid arthritis)
  • At least 30 days since prior and no other concurrent investigational therapy
  • No concurrent external beam radiotherapy
  • No concurrent cytotoxic chemotherapy
  • No other concurrent systemic antineoplastic therapy including, but not limited to, any of the following:

    • Immunotherapy
    • Hormonal therapy
    • Monoclonal antibody therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478075

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United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Study Chair: Angela Dispenzieri, MD Mayo Clinic

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Responsible Party: Angela Dispenzieri, Mayo Clinic Cancer Center Identifier: NCT00478075     History of Changes
Other Study ID Numbers: CDR0000546736
P30CA015083 ( U.S. NIH Grant/Contract )
MC0585 ( Other Identifier: Mayo Clinic Cancer Center )
1586-05 ( Other Identifier: Mayo Clinic IRB )
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: May 11, 2011
Last Verified: May 2011
Keywords provided by Mayo Clinic:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Samarium Sm-153 lexidronam
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs