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

Completed · Phase 1

Conditions studied: Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Waldenstrom Macroglobulinemia

In brief

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

Key facts

Study ID

NCT01118689

Run by

Millennium Pharmaceuticals, Inc.

People needed

39

Starts

2010-11-01

Expected to finish

2013-07-01

Last updated by the study team

2013-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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