ONC201 in Relapsed/Refractory Multiple Myeloma

ONC201 in Relapsed/Refractory Multiple Myeloma

Study Summary

The purpose of this trial is to determine the effectiveness of an investigational drug called ONC201 in combination with a steroid called dexamethasone. An investigational drug is a drug that is being tested and is not approved by the U.S. Food and Drug Administration (FDA). Researchers want to learn whether the intervention works as a potential treatment for people with relapsed/refractory multiple myeloma.

We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. We can use what we learn from this research study to help other people with the same disease. It is anticipated that 42 participants will be in enrolled in this study over the course of 2 years.

Protocol:
  • 15-1060 / IRB15-1060
Phase:
  • II
Investigator:
  • Carlyn Rose Tan
Disease(s):
  • Multiple Myeloma
ClinicalTrials.gov
Location(s):
  • Fox Chase Cancer Center at Cottman Ave

Contact Us
About This Trial:

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515. or fill out this form.

Full Title

A Phase II Study of Oral ONC201 in Relapsed/Refractory Multiple Myeloma

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

    • Must have measurable disease by M protein component in serum or urine
    • Patients must be refractory to, or not a candidate for, established therapy known to provide clinical benefit for their malignancy.
    • All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for at least 14 days (at least 28 days for mitomycin C or nitrosoureas) before study entry.
    • Cannot have active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.

For more information about this and other studies and to enquire about eligibility, please call 215-214-1515.