Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00963820
First received: August 20, 2009
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Relapsed and Refractory Multiple Myeloma
Drug: Oral IXAZOMIB
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Dose-Escalation, Phase 1 Study Evaluating the Safety and Tolerability of Weekly Dosing of the Oral Form of IXAZOMIB (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety profile, tolerability, and maximum tolerated dose (MTD) of IXAZOMIB administered weekly [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics (PK) in plasma of IXAZOMIB [ Time Frame: PK samples are taken during the first month of treatment. ] [ Designated as safety issue: No ]
  • To characterize the pharmacodynamic effect of IXAZOMIB [ Time Frame: Pharmacodynamic samples are taken the first month of treatment. ] [ Designated as safety issue: No ]
  • Disease response following treatment with IXAZOMIB [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2009
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral IXAZOMIB Drug: Oral IXAZOMIB
Patients will be administered IXAZOMIB orally on Days 1, 8, and 15 during a 28-day treatment cycle. Doses will increase until a maximum tolerated dose (MTD) is established.

  Eligibility

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 IXAZOMIB including difficulty swallowing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963820

Locations
United States, Arizona
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
James R. Berenson, MD, Inc
West Hollywood, California, United States, 90069
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Weill-Cornell Medical College
New York City, New York, United States, 10011
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00963820     History of Changes
Other Study ID Numbers: C16004
Study First Received: August 20, 2009
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
Relapsed multiple myeloma
Refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014