Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Ixazomib; Lenalidomide; Dexamethasone
Intervention description: Ixazomib capsules; Lenalidomide capsules; Dexamethasone tablets
Intervention MeSH terms: Dexamethasone; Lenalidomide; Ixazomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this Phase 1 study is to characterize the pharmacokinetic (PK) and
      tolerability of oral ixazomib (MLN9708) when administered in combination with lenalidomide
      and dexamethasone in adult Asian participants with relapsed and/or refractory multiple
      myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female East Asian participants 18 years or older

          -  Diagnosed Multiple Myeloma according to standard criteria

          -  Measurable disease as specified in study protocol

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          -  Participants with relapsed and/or refractory Multiple Myeloma who have received 1 to 3
             prior therapies

          -  Meet the clinical laboratories criteria as specified in the protocol

          -  Female participants who are post menopausal, surgically sterile, or agree to practice
             2 effective methods of contraception or agree to abstain from heterosexual
             intercourse; must also adhere to the guidelines of the lenalidomide pregnancy
             prevention program

          -  Male participants who agree to practice effective barrier contraception or agree to
             abstain from heterosexual intercourse and must adhere to the guidelines of the
             lenalidomide pregnancy prevention program

          -  Must be able to take concurrent aspirin 325 mg daily

          -  Voluntary written consent

        Exclusion Criteria:

          -  Female participants who are lactating or pregnant

          -  Major surgery or radiotherapy within 14 days before enrollment

          -  Infection requiring systematic antibiotics within 14 days before study enrollment

          -  Central nervous system involvement

          -  Failure to have fully recovered from the effects of prior chemotherapy regardless of
             the interval since last treatment

          -  Systemic treatment with strong inhibitors of cytochrome P450 1A2 (CYP1A2), strong
             inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginko biloba or St. John's
             wort within 14 days before study enrollment

          -  Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly,
             endocrinopathy, monoclonal protein, skin changes) syndrome, plasma cell leukemia,
             primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome

          -  Evidence of current uncontrolled cardiovascular conditions

          -  Serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with the completion of treatment according to the protocol

          -  Known allergy to any of the study medications

          -  Known gastrointestinal condition or procedure that could interfere with swallowing or
             the oral absorption of tolerance of ixazomib

          -  Diagnosed or treated for another malignancy within 2 years before study enrollment or
             previously diagnosed with another malignancy and have any evidence of residual disease
             with the exception of nonmelanoma skin cancer or any completely resected carcinoma in
             situ

          -  Ongoing or active systemic infection, active hepatitis B virus infect, active
             hepatitis C infection, or known human immunodeficiency virus (HIV) positive