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An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Formulation of MLN9708, Administered Twice-weekly in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Formulation of MLN9708, Administered Twice-weekly in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment


Inclusion Criteria:



- Male or female patients 18 years or older

- Symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ
damage diagnosed according to standard criteria

- Measurable disease as specified in study protocol

- Hematologic, liver, and renal function as specified in the study protocol Eastern
Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Female patients 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 patients 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

- Peripheral neuropathy that is greater or equal to Grade 2

- Female patients who are lactating or pregnant

- Major surgery or radiotherapy within 14 days before the first dose of study drug

- Uncontrolled infection requiring systematic antibiotics within 14 days before the
first dose of study drug

- Diarrhea (> Grade 1)

- Prior systemic therapy for multiple myeloma, including investigational drugs (prior
treatment with corticosteroids or localized radiation therapy dose not disqualify the
patient)

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

- Central nervous system involvement

- Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS
syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or
myeloproliferative syndrome

- Evidence of current uncontrolled cardiovascular conditions

- Prior or concurrent deep vein thrombosis or pulmonary embolism

- Known human immunodeficiency virus (HIV) positive, hepatitis B surface
antigen-positive status, or known or suspected active hepatitis C infection

- 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 MLN9708

- Diagnosed or treated for another malignancy within 2 years before the first dose 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) and Recommended phase 2 dose of MLN9708 (phase 1)

Outcome Description:

Based on adverse events, serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and vital sign measurements

Outcome Time Frame:

Dose Limiting Toxcities determined in Cycle 1 to define MTD; MTD and adverse events monitored throughout the study will inform the recommended phase 2 dose, approximately 1 year

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C16008

NCT ID:

NCT01383928

Start Date:

July 2011

Completion Date:

January 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Stanford UniversityStanford, California  94305
Hackensack University Medical CenterHackensack, New Jersey  07601
Oregon Health & Science UniversityPortland, Oregon  97201
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637
Moffitt Cancer CenterTampa, Florida  33612
City of Hope Cancer CenterDuarte, California  91010
Ohio State University Comprehensive Cancer CenterColumbus, Ohio  
Mercy St. Vincent Medical CenterToledo, Ohio  43608
Virginia Cancer SpecialistsFairfax, Virginia  
Mount SinaiNew York, New York  10029
Associates in Hematology/OncologyRockville, Maryland  20850
Sara Cannon Research InstituteNashville, Tennessee  37203
Baylor Healthcare SystemDallas, Texas  75204