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Multiple Myeloma

Oral MLN9708 for Relapsed and Refractory Multiple Myeloma (2360)
An Open Label, Dose Escalation, Phase 1 Study Evaluating the Safety and Tolerability of Weekly Dosing of the Oral Form of MLN9708, a Second Generation Proteasome Inhibitor, in Adult patients with Relapsed and Refractory Multiple Myeloma
Status Conditions Phase Study ID
Closed Multiple Myeloma (MM) Phase I 2360.00
NCT00963820
Summary

This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of the weekly dosing MLN9708 administered orally in patients with relapsed and refractory multiple myeloma.


Investigator
Bill Bensinger, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each patient must meet all of the following eligibility criteria to be enrolled in the study:

  • Adult patients with multiple myeloma who have relapsed following at least 2 lines of therapy.
  • Patients must have measurable disease.
  • Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol.
  • Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
  • Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
  • Willing and able to give written informed consent.
  • Suitable venous access for study-required blood sampling.

Exclusion Criteria:

  • Peripheral neuropathy that is greater or equal to Grade 2.
  • Major surgery or, serious infections, or infections that required systematic antibiotic therapy within 14 days before the first dose of study drug.
  • Life-threatening illness unrelated to cancer.
  • Diarrhea that is greater than Grade 1 as outlined in the protocol
  • Systemic antineoplastic or radiation therapy within 14 days or cytotoxic agents, or treatment with any investigational products within 21 days before the first dose of study treatment.
  • Treatment with any investigational proteasome inhibitor.
  • Systemic treatment with prohibited medications that are outlined in the protocol within 14 days of study treatment.
  • Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day.
  • Central nervous system involvement.
  • Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
  • Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
  • Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of tolerance of MLN9708 including difficulty swallowing.
Last Updated
November 15, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.