Trial record 1 of 4 for:    C16014
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IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Millennium Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01850524
First received: April 26, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of IXAZOMIB versus placebo when added to lenalidomide and dexamethasone (LenDex) in patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.


Condition Intervention Phase
Multiple Myeloma
Drug: IXAZOMIB + Lenalidomide + Dexamethasone
Drug: Placebo + Lenalidomide + Dexamethasone
Phase 3

Study Type: 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
Official Title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral IXAZOMIB (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression free survival (PFS) [ 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). ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Complete Response (CR) [ Time Frame: Response assessments will occur every cycle during the treatment period and subsequently every 4 weeks during the PFS follow-up period until disease progression (median length of the endpoint assessment period is projected to be approximately 30 months). ] [ Designated as safety issue: No ]
    Standard multiple myeloma disease assessment

  • Pain response rate as assessed by the BPI-SF and analgesic use [ Time Frame: BPI-SF will be assessed at every cycle during the treatment period and subsequently every 4 weeks during the PFS follow-up period until disease progression (median length of the endpoint assessment period is projected to be approximately 30 months). ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: OS will be assessed at every cycle during the treatment period and subsequently every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination (approximate length of the overall survival period is 60 month) ] [ Designated as safety issue: No ]
    OS is defined as the time from the date of randomization to the date of death.


Estimated Enrollment: 701
Study Start Date: May 2013
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IXAZOMIB
IXAZOMIB + Lenalidomide + Dexamethasone
Drug: IXAZOMIB + Lenalidomide + Dexamethasone
Patients will receive single oral dose of IXAZOMIB (4.0mg) on days 1,8,15 and single oral dose of Lenalidomide (25mg) on days 1-21 and single oral dose of Dexamethasone (40mg) on days 1,8, 15 and 22 every 28 days until disease progression
Placebo Comparator: Placebo
Placebo + Lenalidomide + Dexamethasone
Drug: Placebo + Lenalidomide + Dexamethasone
Patients will receive single oral dose of Placebo on days 1,8,15 and single oral dose of Lenalidomide (25mg) on days 1-21 and single oral dose of Dexamethasone (40mg) on days 1,8, 15 and 22 every 28 days until disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 enoxaparin 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850524

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com

  Show 45 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01850524     History of Changes
Other Study ID Numbers: C16014, 2013-000326-54, U1111-1158-2646
Study First Received: April 26, 2013
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Canada: Health Canada

Keywords provided by Millennium Pharmaceuticals, Inc.:
Newly Diagnosed multiple myeloma
multiple myeloma
MLN9708
IXAZOMIB
Proteasome inhibitor

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on October 01, 2014