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Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01118689
First Posted: May 7, 2010
Last Update Posted: August 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
  Purpose
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia

Condition Intervention Phase
Relapsed Multiple Myeloma Refractory Multiple Myeloma Waldenstrom Macroglobulinemia Drug: MLN0128 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent MLN0128 in Subjects With Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • determine the dose limiting toxicities [ Time Frame: 28-days ]

Enrollment: 39
Study Start Date: November 2010
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MLN0128 Drug: MLN0128
MLN0128 administered orally once daily for 28 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years, including males and females;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
  • Life expectancy of ≥3 months;
  • Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
  • For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
  • Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
  • Ability to swallow oral medications;
  • Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;

Exclusion Criteria:

  • Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.
  • Known impaired cardiac function or clinically significant cardiac disease
  • HIV infection;
  • Failed to recover from the reversible effects of prior anticancer therapies:
  • Pregnancy (positive serum or urine pregnancy test) or breast feeding;
  • Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118689


Locations
United States, California
San Francisco, California, United States, 94143
United States, Colorado
Denver, Colorado, United States, 80218
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01118689     History of Changes
Other Study ID Numbers: INK-128-002
First Submitted: May 5, 2010
First Posted: May 7, 2010
Last Update Posted: August 2, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Waldenstrom Macroglobulinemia
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
Lymphatic Diseases