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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 Newly Diagnosed Multiple Myeloma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
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 Newly Diagnosed Multiple Myeloma


Inclusion Criteria:



- Male or female patients 18 years or older diagnosed with Multiple Myeloma according
to standard criteria who have not received prior treatment

- Patients for whom lenalidomide and dexamethasone treatment is appropriate and who are
not eligible for high-dose therapy followed by stem-cell transplantation (HDT-SCT)
for 1 or more of the following reasons:

1. the patient is 65 years of age or older

2. the patient is less than 65 years of age but has significant comorbid
condition(s) that are, in the opinion of the investigator, likely to have a
negative impact on tolerability of HDT-SCT

- Measurable disease as specified in study protocol

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

- Meet the clinical laboratories criteria as specified in the protocol

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or agree to practice true abstinence, and must
also agree to ongoing pregnancy testing; must also adhere to the guidelines of the
lenalidomide pregnancy prevention program

- Male patients who agree to practice effective barrier contraception or agree to
practice true abstinence AND must adhere to the guidelines of the lenalidomide
pregnancy prevention program

- Suitable venous access for the study-required blood sampling

- Must be able to take concurrent aspirin 70mg to 325 mg daily (or enoxiparin if
aspirin allergic)

- Voluntary written consent

- Patient is willing and able to adhere to the study visit schedule and other protocol
requirements

Exclusion Criteria:

- Prior treatment for multiple myeloma with either standard of care treatment or
investigational regimen

- Diagnosed and treated for another malignancy within 5 years before randomization or
previously diagnosed with another malignancy and have any 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

- Inability or unwillingness to receive antithrombotic therapy

- Female patients who are lactating or pregnant

- Major surgery or radiotherapy within 14 days before randomization

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

- Central nervous system involvement

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

- Evidence of current uncontrolled cardiovascular conditions

- Systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin,
ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin,
itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A
inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital),
or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the
study

- Active hepatitis B or C virus infection, or known human immunodeficiency virus(HIV)
positive

- Comorbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study
or interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2
or higher of any cause)

- 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

- Inability to swallow oral medication, inability or unwillingness to comply with the
drug administration requirements, or gastrointestinal (GI) procedure that could
interfere with the oral absorption or tolerance of treatment

- Treatment with any investigational products within 60 days before the first dose of
the study drug regimen

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:

PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease or death due to any cause, whichever occurs first.

Outcome Time Frame:

PFS will be assessed at every cycle during the treatment period and subsequently every 4 weeks until disease progression (median length of the endpoint assessment period is projected to be approximately 30 months).

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:

C16014

NCT ID:

NCT01850524

Start Date:

May 2013

Completion Date:

February 2021

Related Keywords:

  • Multiple Myeloma
  • Newly Diagnosed multiple myeloma
  • multiple myeloma
  • MLN9708
  • Proteasome inhibitor
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Arizona Clinical Research CenterTucson, Arizona  85712
Associates in Oncology and HematologyChattanooga, Tennessee  37404
Cancer Care of North FloridaLake City, Florida  32055
Cancer Center of Central ConnecticutSouthington, Connecticut  
Medical Oncology AssociatesSpokane, Washington  99208
Sutter Health Santa RosaSanta Rosa, California  95403