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

This study has been completed.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc. Identifier:
First received: May 5, 2010
Last updated: July 31, 2013
Last verified: July 2013
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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01118689

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.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01118689     History of Changes
Other Study ID Numbers: INK-128-002 
Study First Received: May 5, 2010
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases processed this record on February 11, 2016