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Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain

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: NCT00482378
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : August 14, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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. Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam pentasodium together with zoledronic acid or pamidronate may be an effective treatment for multiple myeloma.

PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Pain Drug: Pamidronate Drug: Zoledronic acid Radiation: Sm 153 lexidronam Phase 1 Phase 2

Detailed Description:



  • Determine the safety and tolerability of samarium Sm 153 lexidronam pentasodium in combination with zoledronic acid or pamidronate disodium in patients with relapsed or refractory multiple myeloma and bone pain. (Phase I)
  • Determine the clinical response in patients treated with these regimens. (Phase II)


  • Determine the effect of these regimens on changes in patient-reported bone pain levels.

OUTLINE: This is a multicenter, open-label, pilot, phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study.

  • Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV over 1 minute on day 1. Patients also receive zoledronic acid IV over 15 minutes or pamidronate disodium IV over 2-4 hours on day 1 and then monthly thereafter in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of samarium Sm 153 lexidronam pentasodium 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 at the MTD determined in phase I and zoledronic acid or pamidronate disodium as in phase I.

Bone pain is assessed periodically.

After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Pilot Study of Samarium - Sm 153 Lexidronam (Quadramet) in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
Actual Study Start Date : March 21, 2005
Actual Primary Completion Date : May 22, 2007
Actual Study Completion Date : December 2, 2008

Arm Intervention/treatment
Experimental: Sm 153 lexidronam Drug: Pamidronate
90 mg by IV monthly.
Other Name: Aredia

Drug: Zoledronic acid
4 mg by IV monthly.
Other Name: Zometa

Radiation: Sm 153 lexidronam
0.5 mCi/kg or 1 mCi/kg by IV.
Other Name: Sm 153 lexidronam consists of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP).

Primary Outcome Measures :
  1. Toxicity (Phase I) [ Time Frame: 12 weeks ]
  2. Confirmed clinical response of serum and urine monoclonal protein (Phase II) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Response (Phase I) [ Time Frame: 12 weeks ]
  2. Bone pain response (Phase II) [ Time Frame: 12 weeks ]
  3. Toxicity (Phase II) [ Time Frame: 12 weeks ]

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 to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of multiple myeloma

    • Relapsed or refractory disease, meeting 1 of the following criteria:

      • Recurrent disease after stem cell transplantation
      • Recurrent or progressive disease despite treatment with ≥ 1 standard regimen (e.g., an alkylating agent plus glucocorticoid and/or the combination of vincristine, doxorubicin hydrochloride, and dexamethasone)
  • Measurable or evaluable disease, defined by at least 1 of the following:

    • Monoclonal protein ≥ 1.0 g by serum 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)
  • Patients must have already undergone hematopoietic stem cell collection, if believed to be a transplant candidate OR not eligible for a hematopoietic stem cell transplant


  • ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain)
  • ANC ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
  • 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 active malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
  • No uncontrolled infection
  • No other co-morbidity that would interfere with the patient's ability to participate in this trial
  • No known hypersensitivity to any of the components of samarium Sm 153 lexidronam pentasodium or bisphosphonates


  • Recovered from all prior surgery, radiotherapy, or other antineoplastic therapy
  • More than 4 weeks since prior melphalan or other myelosuppressive agents
  • More than 2 weeks since prior nonmyelosuppressive agents (e.g., thalidomide or high-dose corticosteroids)
  • More than 30 days since prior and no other concurrent investigational therapy
  • No prior samarium Sm 153 lexidronam pentasodium or strontium chloride Sr 89
  • No concurrent external beam radiotherapy
  • No concurrent high-dose corticosteroids

    • Concurrent chronic steroids (maximum dose of 20 mg/day prednisone equivalent) allowed for disorders other than myeloma (i.e., adrenal insufficiency or rheumatoid arthritis)
    • Low-dose steroids allowed for replacement or inhalation therapy
  • No other concurrent medications, including any of the following:

    • Cytotoxic chemotherapy
    • Systemic antineoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy
    • Prophylactic hematopoietic growth factors

      • Hematopoietic growth factors allowed for established cytopenia 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): NCT00482378

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Study Chair: Angela Dispenzieri, M.D. Mayo Clinic
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Responsible Party: Mayo Clinic Identifier: NCT00482378    
Other Study ID Numbers: CDR0000546769
P30CA015083 ( U.S. NIH Grant/Contract )
MC048B ( Other Identifier: Mayo Clinic Cancer Center )
261-05 ( Other Identifier: Mayo Clinic IRB )
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
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
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs