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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

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ClinicalTrials.gov Identifier: NCT00482378
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 4, 2007
First Posted Date  ICMJE June 5, 2007
Last Update Posted Date August 14, 2018
Actual Study Start Date  ICMJE March 21, 2005
Actual Primary Completion Date May 22, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
  • Toxicity (Phase I) [ Time Frame: 12 weeks ]
  • Confirmed clinical response of serum and urine monoclonal protein (Phase II) [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
  • Toxicity (Phase I)
  • Confirmed clinical response of serum and urine monoclonal protein (Phase II)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
  • Response (Phase I) [ Time Frame: 12 weeks ]
  • Bone pain response (Phase II) [ Time Frame: 12 weeks ]
  • Toxicity (Phase II) [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
  • Response (Phase I)
  • Bone pain response (Phase II)
  • Toxicity (Phase II)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
Official Title  ICMJE An Open-Label, Pilot Study of Samarium - Sm 153 Lexidronam (Quadramet) in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
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.

Detailed Description

OBJECTIVES:

Primary

  • 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)

Secondary

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Pain
Intervention  ICMJE
  • 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).
Study Arms  ICMJE Experimental: Sm 153 lexidronam
Interventions:
  • Drug: Pamidronate
  • Drug: Zoledronic acid
  • Radiation: Sm 153 lexidronam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 4, 2007)
39
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2, 2008
Actual Primary Completion Date May 22, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00482378
Other Study ID Numbers  ICMJE CDR0000546769
P30CA015083 ( U.S. NIH Grant/Contract )
MC048B ( Other Identifier: Mayo Clinic Cancer Center )
261-05 ( Other Identifier: Mayo Clinic IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Angela Dispenzieri, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP