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

August 20, 2009
May 23, 2014
November 2009
January 2013   (final data collection date for primary outcome measure)
Safety profile, tolerability, and maximum tolerated dose (MTD) of IXAZOMIB administered weekly [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Safety profile, tolerability, and maximum tolerated dose (MTD) of MLN9708 administered weekly [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00963820 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To characterize the pharmacokinetics (PK) in plasma of MLN9708 [ Time Frame: PK samples are taken during the first month of treatment. ] [ Designated as safety issue: No ]
  • To characterize the pharmacodynamic effect of MLN9708 [ Time Frame: Pharmacodynamic samples are taken the first month of treatment. ] [ Designated as safety issue: No ]
  • Disease response following treatment with MLN9708 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma
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

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsed and Refractory Multiple Myeloma
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.
Experimental: Oral IXAZOMIB
Intervention: Drug: Oral IXAZOMIB
Kumar SK, Bensinger WI, Zimmerman TM, Reeder CB, Berenson JR, Berg D, Hui AM, Gupta N, Di Bacco A, Yu J, Shou Y, Niesvizky R. Phase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma. Blood. 2014 Aug 14;124(7):1047-55. doi: 10.1182/blood-2014-01-548941. Epub 2014 Jun 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00963820
C16004
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP