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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01118689

Enrollment

Registered

2010-05-07

Start date

2010-11-30

Completion date

2013-07-31

Last updated

2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Waldenstrom Macroglobulinemia

Brief summary

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

Interventions

DRUGMLN0128

MLN0128 administered orally once daily for 28 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
determine the dose limiting toxicities	28-days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026