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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Relapsed and Refractory Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety profile, tolerability, and maximum tolerated dose (MTD) of MLN9708 administered weekly

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C16004

NCT ID:

NCT00963820

Start Date:

November 2009

Completion Date:

April 2013

Related Keywords:

  • Relapsed and Refractory Multiple Myeloma
  • Relapsed multiple myeloma
  • Refractory multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mayo ClinicRochester, Minnesota  55905
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of ChicagoChicago, Illinois  60637
Mayo Clinic- ScottsdaleScottsdale, Arizona  85259
James R. Berenson, MD, IncWest Hollywood, California  90069
Weill-Cornell Medical CollegeNew York City, New York  10011