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Quadramet (Samarium SM 153 Lexidronam Pentasodium) - Summary

 
 



QUADRAMET SUMMARY

QUADRAMET® is a therapeutic agent consisting of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP). QUADRAMET® is formulated as a sterile, non-pyrogenic, clear, colorless to light amber isotonic solution of samarium-153 lexidronam for intravenous administration. QUADRAMET® does not contain a preservative. Each milliliter contains 35 mg EDTMP•H2O, 5.3 mg Ca [as Ca(OH)2], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP (anhydrous calc.), 5-46 µg samarium (specific activity of approximately 1.0-11.0 mCi/µg Sm), and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.

QUADRAMET® is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.


See all Quadramet indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)

Why being double-jointed can be a pain in the gut
Source: Bones / Orthopedics News From Medical News Today [2014.04.17]
Scientists from Queen Mary University of London are carrying out groundbreaking research which, for the first time, investigates the link between hypermobility (double-jointedness) and gut...

Intelligent prosthetic liners could ease pain for lower limb amputees
Source: Medical Devices / Diagnostics News From Medical News Today [2014.04.16]
A new device could help to relieve the pain and discomfort experienced by thousands of amputees as a result of poorly fitting replacement lower limbs.

Safe Epidurals, Hydrocodone Rescheduling: The Pain Medicine News Report
Source: MedPage Today Emergency Medicine [2014.04.16]
(MedPage Today) -- A regular update on what's new in surgery from our friends at Pain Medicine News.

Chronic Pain
Source: MedicineNet Alternative Medicine Specialty [2014.04.15]
Title: Chronic Pain
Category: Diseases and Conditions
Created: 5/14/2002 12:00:00 AM
Last Editorial Review: 4/15/2014 12:00:00 AM

Taking Blood Thinners With Certain Painkillers May Raise Bleeding Risk
Source: MedicineNet Atrial Fibrillation Specialty [2014.04.15]
Title: Taking Blood Thinners With Certain Painkillers May Raise Bleeding Risk
Category: Health News
Created: 4/14/2014 4:36:00 PM
Last Editorial Review: 4/15/2014 12:00:00 AM

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Published Studies Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)

[Cost-effectiveness analysis of samario-153 (Quadramet) for the treatment of patients with prostate cancer and bone metastases] [2005.06]
CONCLUSION: Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.

A comparative study of samarium-153-ethylenediaminetetramethylene phosphonic acid with pamidronate disodium in the treatment of patients with painful metastatic bone cancer. [2003.04]
CONCLUSION: The data showed that the therapeutic efficacy of (153)Sm-EDTPM was higher than that of pamidronate disodium (for pain relief maintained more than 3 weeks) and its incidence of blood toxicity was also higher than that of pamidronate disodium. Copyright 2003 S. Karger AG, Basel

Multicentre trial on the efficacy and toxicity of single-dose samarium-153-ethylene diamine tetramethylene phosphonate as a palliative treatment for painful skeletal metastases in China. [1999.01]
A multicentre trial was organized in China as part of an international coordinated research project to study the efficacy and toxicity of single-dose samarium-153 ethylene diamine tetramethylene phosphonate (EDTMP) as a palliative treatment for painful skeletal metastases... Further studies are needed to identify better ways of determining the appropriate dose in the individual case and the efficacy of treatment.

Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. [1998.04]
PURPOSE: To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study... CONCLUSION: A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.

Adverse events in the long-term follow-up of patients treated with samarium Sm 153 lexidronam for osseous metastases. [2011.10.01]
CONCLUSIONS: Our observation of new-onset, acute and transient edema and neuropathy after samarium Sm 153 lexidronam and of a relationship between edema and post-samarium Sm 153 lexidronam chemotherapy suggests the need for re-examination of patients in past series or for a prospective investigation with nonhematologic adverse events as a primary endpoint. Copyright (c) 2011 Elsevier Inc. All rights reserved.

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Clinical Trials Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)

153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer [Recruiting]
Background:

- No treatment is known to improve survival for prostate cancer patients who have not

been helped by previous treatments with hormones and chemotherapy.

- An experimental vaccine called PSA/TRICOM contains genes for a protein produced by

prostate cancer cells called prostate-specific antigen (PSA). The vaccine can trigger the immune system to make cells that may be able to recognize and attack the cancer cells that make PSA.

- GM-CSF is an approved drug that is usually given to increase a patient's white blood

cell count or to stimulate the immune system.

- 153Sm-EDTMP is a radioactive drug that has been approved for many years to treat

advanced prostate cancer. It is given through a vein and can be targeted directly to tumors in the bone where it can relieve pain caused by bone lesions. Radiation also increases the level of certain proteins inside the tumor, making it easier for the immune system to find and kill the tumor cells.

- When laboratory mice were given just vaccine, just radiation, or a combination of both,

the combination was most effective in treating tumors.

Objectives:

- To determine if combined treatment with PSA/TRICOM vaccine and 153Sm-EDTMP radiation can

delay progression of prostate cancer better than radiation alone.

Eligibility:

- Patients who have advanced prostate cancer that has worsened despite treatments with

hormones, have two or more bone lesions related to their prostate cancer, and have had prior treatment with docetaxel chemotherapy.

Design:

- Patients are randomly assigned to receive radiation alone (Arm A) or radiation with

vaccine and sargramostim (Arm B).

- Arm A receives 153Sm-EDTMP radiation starting on study day 8 and repeated every 12

weeks.

- Arm B receives a priming vaccine on study day 1 and radiation on day 8. Radiation

therapy is repeated every 12 weeks. Boosting vaccines are given on days 15 and 29 and then monthly. GM-CSF is given with each vaccination (on the day of the vaccination and for the next 3 days) to enhance the immune response. Vaccinations and GM-CSF are given as injections under the skin, usually in the thigh. Radiation therapy is given through a vein.

- Patients are monitored regularly with physical examinations, blood and urine tests, and

scans to evaluate safety and treatment response.

- Patients who are HLA-A2-positive undergo apheresis, a procedure similar to donating

blood, for obtaining immune cells called lymphocytes to measure the immune response to the vaccine.

Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases [Recruiting]
Primary objectives:

- To determine the time to progression in subjects with breast cancer metastatic to bone

only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).

Secondary objectives:

- To determine the overall survival at one year.

- To determine the efficacy of 153Sm-EDTMP at 6 months.

- To assess pain in subjects treated with 153Sm-EDTMP.

- To determine the safety of 153Sm-EDTMP.

Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma [Active, not recruiting]
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.

Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain [Active, not recruiting]
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.

Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer [Recruiting]
The purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer.

more trials >>


Page last updated: 2014-04-17

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