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FDA Places Hold on Multiple Myeloma Studies Following Patient Deaths


The U.S. Food and Drug Administration (FDA) has placed clinical holds on three separate multiple myeloma studies following reports of patient deaths.

Clinical Hold Marks Set Back for Certain Keytruda Combination Therapies

According to Reuters, all three clinical trials were testing Merck’s drug Keytruda in combination with other medicines for treatment of patients with multiple myeloma. Combinations included Celgene Corp’s standard multiple myeloma regimens Revlimid and Pomoalyst.

Merck halted patient enrollment in the trials last month after independent safety monitors observed more deaths in patients receiving Keytruda combination therapies than in control groups.

All patients who were receiving Keytruda in combination with one of the Celgene drugs will no longer take Keytruda.

Other Side Effects Associated with Keytruda

According to WebMD, the following adverse events have been reported in patients receiving Keytruda:

  • Cellulitis
  • Hypothyroidism
  • Anemia
  • Inflammation in the Lungs
  • Inflammation of the Large Intestine
  • Inflammation of the Pituitary Gland
  • Sepsis
  • Diabetes
  • Kidney Failure
  • Liver Inflammation
  • Seizures
  • Pancreatitis
  • Sudden Blindness

 

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