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

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;