Know Cancer

or
forgot password

A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Relapsed Multiple Myeloma, Refractory Multiple Myeloma

Thank you

Trial Information

A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma


Inclusion Criteria:



- Male or female patients 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

- Patients 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

- Patients who received prior allogenic transplant must have no active
graft-versus-host disease (GVHD)

- 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:

- Patient who were refractory to lenalidomide or proteasome inhibitor-based therapy

- Female patients who are lactating or pregnant

- Major surgery or radiotherapy within 14 days before randomization

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

- 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 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

- Diagnosis of Waldenstrom's macroglobulinemia, POEMS 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 MLN9708

- Diagnosed or treated for another malignancy within 2 years before randomization 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Description:

To determine whether the addition of oral MLN9708 to the background therapy of lenalidomide and dexamethasone improves PFS in patients with relapsed and/or refractory multiple myeloma

Outcome Time Frame:

Change from the time of screening; Day 1 of each cycle; at EOT and thereafter every 4 weeks until disease progression

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:

C16010

NCT ID:

NCT01564537

Start Date:

June 2012

Completion Date:

May 2019

Related Keywords:

  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Relapsed multiple myeloma
  • Refractory multiple myeloma
  • MLN9708
  • Proteasome inhibitor
  • Tourmaline-MM1
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Medical College of WisconsinMilwaukee, Wisconsin  53226
Hackensack University Medical CenterHackensack, New Jersey  07601
Weill Medical College of Cornell UniversityNew York, New York  10021
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Arizona Oncology AssociatesTucson, Arizona  85712-2254
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Kentucky Cancer ClinicPikeville, Kentucky  41501
University of Arkansas Medical SciencesLittle Rock, Arkansas  72205
Clearview Cancer InstituteHuntsville, Alabama  35805
Jones ClinicGermantown, Tennessee  38138
Portsmouth Regional HospitalPortsmouth, New Hampshire  03802
Columbia University Medical CenterNew York, New York  10032
Scranton Hematology OncologyScranton, Pennsylvania  18510
West Virginia UniversityMorgantown, West Virginia  26506
Cancer and Blood Disease CenterLecanto, Florida  34461
MUSC Hollings Cancer CenterCharleston, South Carolina  29425
Cancer Care of North FloridaLake City, Florida  32055
Northwest Georgia Oncology CenterMarietta, Georgia  30060
Blood and Cancer ClinicFayetteville, North Carolina  28304
Pacific Cancer Medical Center IncorporatedAnaheim, California  92801
Shands Hospital at University of FloridaGainesville, Florida  32610
John H. Stroger Jr. Hospital of Cook CountyChicago, Illinois  60612
Fred Hutchinson Cancer ResearchSeattle, Washington  98109