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Phase 1/1b Pharmacokinetics Study of Oral MLN9708 Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients With Normal Renal Function or Severe Renal Impairment


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Phase 1/1b Pharmacokinetics Study of Oral MLN9708 Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients With Normal Renal Function or Severe Renal Impairment


Inclusion Criteria:



- Male or female patients 18 years or older

- Multiple myeloma (MM) diagnosed according to standard criteria

- Patients with relapsed/refractory multiple myeloma after at least 1 prior therapy

- A calculated creatinine clearance (CrCl) that meets entry criteria for enrollment
(ie, calculated CrCl either ≥ 90 or < 30 mL/min, including patients currently on
hemodialysis)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception through 90 days after the last dose of study drug
or agree to practice true abstinence

- Male patients who agree to practice effective barrier contraception through 90 after
the last dose of study drug or agree to practice true abstinence

- Voluntary written informed consent

- Suitable venous access

Exclusion Criteria:

- Female patients who are pregnant or breastfeeding

- Failure to have recovered from clinically significant effects of prior chemotherapy
(defined as toxicity greater than Grade 1 with the exception of alopecia)

- Major surgery or radiotherapy within 14 days before study drug administration

- Dexamethasone (or equivalent systemic steroid) higher than the physiologic dosing
with 7 days before study drug administration

- Central nervous system involvement

- Infection requiring systemic antibiotic therapy or other serious infection within 14
days prior to first dose of study drug

- Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly,
endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell
leukemia, myeloproliferative syndrome, or primary amyloidosis (with the exception of
patients in whom amyloidosis has been documented as a complication of MM, who will be
evaluated on a case-by-case basis for trial participation)

- Systemic treatment with strong and moderate inhibitors of CYP1A2, strong and moderate
inhibitors of CYP3A, or clinically significant CYP3A inducers or use of Ginkgo biloba
or St. John's wort within 14 days before the first dose of study drug

- Evidence of uncontrolled cardiovascular conditions

- Ongoing or active systemic infection, active hepatitis B or C virus infection, or
known human immunodeficiency virus (HIV) positive

- Comorbid systemic illness or psychiatric illness that could interfere with study
completion

- Known allergy to study medications

- Inability to swallow oral medication or condition that could interfere with oral
absorption or tolerance of treatment

- Diagnosis or treated for another invasive malignancy within 2 years before
enrollment, OR previously diagnosed with another malignancy with current evidence of
residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any
type are not excluded if they have undergone complete resection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean single-dose maximum (peak) concentration (Cmax) of MLN9708

Outcome Description:

Plasma PK parameter

Outcome Time Frame:

Assessed on Days 1-15 of Part A

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C16015

NCT ID:

NCT01830816

Start Date:

May 2013

Completion Date:

October 2015

Related Keywords:

  • Multiple Myeloma
  • Relapsed
  • Refractory
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Sarah Cannon Research InstituteNashville, Tennessee  37203
Institute of Oncology Hematology Biomedical Research LLCLaredo, Texas  78041