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An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of MLN9708, a Second-Generation Proteasome Inhibitor, Administered in Combination With Lenalidomide and Low-Dose 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 Form of MLN9708, a Second-Generation Proteasome Inhibitor, Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment


Inclusion Criteria:



Each patient must meet all of the following eligibility criteria to be enrolled in the
study:

- Male or female patients 18 years or older

- Previously untreated multiple myeloma diagnosed according to standard criteria
requiring systemic treatment

- Patients must have measurable disease

- Nosecretory multiple myeloma based upon standard M-component criteria (i.e.,
measurable serum/urine M-component) is not allowed unless the baseline serum free
light chain level (Freeliteā„¢) is evaluated Patients must meet clinical laboratory
criteria as specified in study protocol

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Female and male patients 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

Patients meeting any of the following exclusion criteria are not to be enrolled in the
study:

- 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

- Serious infection requiring systematic antibiotic therapy within 14 days before the
first dose of study drug

- Diarrhea greater than Grade 1 based on the National Cancer Institute Common
Terminology Criteria for Adverse Events

- Central nervous system involvement.

- Evidence of current uncontrolled cardiovascular conditions within the past 6 months

- 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 gastrointestinal condition that could interfere with swallowing or the oral
absorption of tolerance of MLN9708

- No other prior malignancy within 2 years except nonmelanoma skin cancer or carcinoma
in situ of any type if they have undergone complete resection

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

To determine the safety and tolerability of MLN9708 administered weekly in combination with lenalidomide and low-dose dexamethasone

Outcome Time Frame:

Until occurrence of progressive disease or unacceptable toxicity

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:

C16005

NCT ID:

NCT01217957

Start Date:

November 2010

Completion Date:

April 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Cedars-Sinai Medical CenterLos Angeles, California  90048
Rocky Mountain Cancer CenterDenver, Colorado  80218
Mayo ClinicJacksonville, Florida  32224
Emory UniversityAtlanta, Georgia  30322
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Mount Sinai Medical CenterMiami Beach, Florida  33140
The Harry and Jeanette Weinberg Cancer InstituteBaltimore, Maryland  21237-3998
Karmanos Cancer InstituteDetroit, Michigan  48201
Tennessee OncologyNashville, Tennessee  37203
Cancer Center of Central ConnecticutSouthington, Connecticut  
Medical College WisconsinMilwaukee, Wisconsin  
Mayo Clinic- ScottsdaleScottsdale, Arizona  85259
Weill-Cornell Medical CollegeNew York City, New York  10011
Mayo Clinic- RochesterRochester, Minnesota  55095
Mary Babb Rudolph Cancer CenterMorgantown, West Virginia  26506