ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01564537
Recruitment Status : Active, not recruiting
First Posted : March 28, 2012
Results First Posted : January 27, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).

Condition or disease Intervention/treatment Phase
Relapsed Multiple Myeloma Refractory Multiple Myeloma Drug: Ixazomib Drug: Lenalidomide Drug: Dexamethasone Drug: Placebo Phase 3

Detailed Description:

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (RRMM). This study will look at progression free survival (PFS), overall survival (OS) and safety in participants who take ixazomib in addition to lenalidomide and dexamethasone compared to placebo in addition to lenalidomide and dexamethasone.

The study enrolled 722 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Ixazomib 4 mg + lenalidomide + dexamethasone
  • Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient + lenalidomide + dexamethasone

All participants will receive treatment in 28 day cycles until disease progression or unacceptable toxicity.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 80 months. Participants will make multiple visits to the clinic, and will be contacted every 4 weeks for PFS and every 12 weeks for OS.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 722 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : August 1, 2012
Actual Primary Completion Date : October 1, 2014
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Experimental: Ixazomib + Lenalidomide + Dexamethasone
Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (EOT) projected at 80 months.
Drug: Ixazomib
Ixazomib capsules
Other Names:
  • MLN9708
  • NINLARO®

Drug: Lenalidomide
Lenalidomide capsules

Drug: Dexamethasone
Dexamethasone tablets

Placebo Comparator: Placebo + Lenalidomide + Dexamethasone
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
Drug: Lenalidomide
Lenalidomide capsules

Drug: Dexamethasone
Dexamethasone tablets

Drug: Placebo
Ixazomib placebo-matching capsules




Primary Outcome Measures :
  1. Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) [ Time Frame: From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months) ]
    Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Date of randomization until death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months) ]
    Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.

  2. Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)] [ Time Frame: At the time of screening; Day 1 of each cycle (every 4 weeks) until disease progression and thereafter every 12 weeks until death or study termination ]
    Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.

  3. Overall Response Rate (ORR) as Assessed by the IRC [ Time Frame: Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months) ]
    ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria.

  4. Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) as Assessed by the IRC [ Time Frame: Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months) ]
    Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.

  5. Duration of Response (DOR) [ Time Frame: Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months) ]
    DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR [including sCR] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria.

  6. Time to Progression (TTP) as Assessed by the IRC [ Time Frame: Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months) ]
    TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria.

  7. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the date of signing of the informed consent form through 30 days after the last dose of study drug up to data cut-off: 30 October 2014 (approximate median follow-up 15 months) ]
    Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.

  8. Percentage of Participants Achieving Pain Response [ Time Frame: At screening; Day 1 of each cycle; and thereafter every 4 weeks until disease progression ]
    Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity ("worst," "least," "average," and "now" [current pain]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain severity items are rated on a 0 to 10 scale where: 0=no pain and 10=pain as bad as you can imagine and averaged for a total score of 0 (best) to 10 (Worst).

  9. Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30) [ Time Frame: Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up ]
    The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.

  10. Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20) [ Time Frame: Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up ]
    The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement.

  11. OS in High-Risk Participants [ Time Frame: At the time of screening; Day 1 of each cycle; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination ]
    Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.

  12. PFS in High-Risk Participants [ Time Frame: From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months) ]
    Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis.

  13. Pharmacokinetic Parameters (Including Cmax, AUC and Tmax) of Ixazomib [ Time Frame: Days 1 & 14 of Cycles 1 & 2. Day 1 of Cycles 3 to 10 ]
  14. Association Between Response or Resistance to Ixazomib Treatment and Proteasome and Nuclear Factor-kB (NF-kB)-Related Genes [ Time Frame: At the time of screening; Day 1 of each cycle; at EOT; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female participants 18 years of age or older.
  2. Multiple myeloma diagnosed according to standard criteria either currently or at the time of initial diagnosis.

    NOTE: The initial diagnosis must have been symptomatic multiple myeloma, although the relapsed disease did not need to be symptomatic.

  3. Must have had measurable disease, defined by at least 1 of the following 3 measurements:

    • Serum M-protein ≥ 1 g/dL (≥ 10 g/L).
    • Urine M-protein ≥ 200 mg/24 hours.
    • Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (≥ 100 mg/L), provided that the serum FLC ratio was abnormal.
  4. Participants with relapsed and/or refractory multiple myeloma (RRMM) who had received 1 to 3 prior therapies.

    NOTE: population included the following 3 categories of participants:

    • Participants who relapsed from their previous treatment(s) but were not refractory to any previous treatment.
    • Participants who were refractory to all lines of previous treatment(s) (ie, participants who had never responded to any therapies received).
    • Participants who relapsed from at least 1 previous treatment AND additionally were refractory to at least 1 previous treatment. For the purposes of this study, refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of a given therapy.

    A line of therapy was defined as 1 or more cycles of a planned treatment program. This may have consisted of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. For example, a planned treatment approach of induction therapy followed by autologous stem cell transplantation, followed by maintenance was considered 1 line of therapy. Autologous and allogenic transplants were permitted.

  5. Must have met the following clinical laboratory criteria:

    • Absolute neutrophil count (ANC) ≥ 1000/mm^3 and platelet count ≥ 75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria were not allowed within 3 days prior to randomization.
    • Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
    • Calculated creatinine clearance ≥ 30 mL/min NOTE: Participants with a low creatinine clearance ≤ 60 mL/min (or ≤ 50 mL/min, according to lenalidomide prescribing information/local practice) were to receive a reduced lenalidomide dose of 10 mg once daily (QD) on Days 1 through 21 of a 28-day cycle. The lenalidomide dose may have been escalated to 15 mg QD after 2 cycles if the participant was not responding to treatment and was tolerating the treatment. If renal function normalized (ie, creatinine clearance >60 mL/min or >50 mL/min, according to lenalidomide prescribing information/local practice) and the participant continued to tolerate this treatment, lenalidomide may then have been escalated to 25 mg QD.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  7. Participants who received prior allogenic transplant must have had no active graft-versus-host disease.
  8. Female participants who:

    • Were postmenopausal for at least 24 months before the screening visit, OR
    • Were surgically sterile, OR
    • If they were of childbearing potential must have: had a negative pregnancy test with a sensitivity of at least 25 mIU/mL within 10 to 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide; either agreed to practice true abstinence, when this was in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal were not acceptable methods of contraception.) OR begun 2 reliable methods of birth control (1 highly effective method and 1 additional effective method) at the same time, at least 28 days before starting study treatment through 90 days after the last dose of study treatment; and agreed to ongoing pregnancy testing AND must have also adhered to the guidelines of the RevAssist program (US participants), RevAid program (Canadian participants), iAccess program (Australian participants), RevMate program (Japanese participants) or The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the Study Manual (all other participants who were not using commercial supplies).

    Male patients, even if surgically sterilized (ie, status postvasectomy), who:

    • Agreed to practice true abstinence, when this was in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal were not acceptable methods of contraception.) OR
    • Agreed to practice effective barrier contraception during the entire study treatment period and 90 days after the last dose of study treatment if their partner was of childbearing potential, even if they had a successful vasectomy, AND
    • Must have also adhered to the guidelines of the RevAssist program (US participants), RevAid program (Canadian participants), iAccess program (Australian participants), RevMate program (Japanese participants) or The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the study Manual (all other participants who were not using commercial supplies)
  9. Must have been able to take concurrent aspirin 81 to 325 mg daily (or enoxaparin 40 mg subcutaneously daily [or its equivalent] if allergic to aspirin), per published standard or institutional standard of care, as prophylactic anticoagulation.

    NOTE: For participants with prior history of deep vein thrombosis (DVT), low-molecular-weight heparin (LMWH) was mandatory.

  10. Voluntary written consent must have been given before performance of any study related procedure not part of standard medical care, with the understanding that consent may have been withdrawn by the participant at any time without prejudice to future medical care.
  11. Was willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  1. Was refractory to lenalidomide or proteasome inhibitor-based therapy at any line.

    NOTE: Refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of a given therapy. Participants who progressed after 60 days from the last dose of a given therapy were considered relapsed and were eligible for inclusion in the study.

    Participants who were refractory to thalidomide-based therapy were eligible.

  2. Female participants who were breast feeding or pregnant.
  3. Failure to have fully recovered (ie, Grade 1 toxicity) from the effects of prior chemotherapy (except for alopecia) regardless of the interval since last treatment.
  4. Major surgery within 14 days before randomization.
  5. Radiotherapy within 14 days before randomization.
  6. Central nervous system involvement.
  7. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before randomization.
  8. Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
  9. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6 months before randomization in the study.
  10. Systemic treatment with strong inhibitors of cytochrome P450 (CYP) 1A2 (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.
  11. Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.
  12. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant 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).
  13. Psychiatric illness/social situation that would limit compliance with study requirements.
  14. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  15. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal condition that could interfere with the oral absorption or tolerance of treatment.
  16. Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type were not excluded if they had undergone complete resection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564537


  Hide Study Locations
Locations
United States, California
Pacific Cancer Medical Center Inc
Anaheim, California, United States, 92801
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Cancer & Blood Disease Center
Lecanto, Florida, United States, 34461
United States, Georgia
Northwest Georgia Oncology Center
Marietta, Georgia, United States, 30060
United States, Illinois
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
Blood and Cancer Clinic
Fayetteville, North Carolina, United States, 28303
United States, Pennsylvania
Scranton Hematology Oncology
Scranton, Pennsylvania, United States, 18510
United States, South Carolina
MUSC Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Washington
Fred Hutchinson Cancer Research
Seattle, Washington, United States, 98109
United States, West Virginia
West Virginia University Hospitals and Clinic
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Cancer Trials Australia
Heidelberg, Victoria, Australia, 3084
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Austria
Medizinische Universitat Graz
Graz, Austria, 8036
Salzburger Landeskliniken
Salzburg, Austria, 5020
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Wilhelminenspital der Stadt Wien
Wien, Austria, 1160
Belgium
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
Antwerpen, Belgium, 2060
UZ Brussel
Brussel, Belgium, 1090
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Centre Hospitalier Universitaire Ambroise Pare
Mons, Belgium, 7000
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium, 5530
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Quebec
MUHC Glen Site Cedars Cancer Centre
Montreal, Quebec, Canada, H4A 3J1
China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China, 310003
Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
Tianjin, China, 300020
Czechia
Fakultni nemocnice Brno
Brno, Czechia, 63900
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Olomouc
Olomouc, Czechia, 775 20
Fakultni nemocnice Ostrava
Ostrava, Czechia, 708 52
Fakultni nemocnice Kralovske Vinohrady
Praha 10, Czechia, 100 34
Denmark
Aalborg Sygehus
Aalborg, Denmark, DK-9000
Aarhus Universitetshospital
Arhus C, Denmark, DK-8000
Rigshospitalet
Kobenhavn O, Denmark, DK-2100
France
Hopital Claude Huriez
Lille, France, 59000
Hopital Universitaire Dupuytren
Limoges, France, 87042
Institut Paoli Calmettes
Marseille, France, 13273
Hopital Saint Eloi
Montpellier, France, 34295
Hotel-Dieu
Nantes, France, 44093
Hopital Saint Louis
Paris, France, 75475
Hopital Saint Antoine
Paris, France, 75571
Hopitaux du Haut Leveque
Pessac, France, 33600
Hopital Pontchaillou
Rennes, France, 35019
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31059
Hopital Bretonneau
Tours, France, 37044
Germany
Universitatsklinikum Dusseldorf
Dusseldorf, Germany, 40225
Asklepios Klinik Altona
Hamburg, Germany, 20099
Hamatologische / Onkologische Praxisgemeinschaft Dres. H. Them/H.-D.Schick/D.Schick
Munchen, Germany, 81241
Universitatsklinikum Ulm
Ulm, Germany, 89081
Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
Budapest, Hungary, 1097
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, Hungary, 4032
Bekes Megyei Kozponti Korhaz
Gyula, Hungary, 5700
Israel
Rambam Health Care Campus
Haifa, Israel, 3525408
Hadassah University Hospital Ein Kerem
Jerusalem, Israel, 9112001
Meir Medical Center
Kfar Saba, Israel, 44281
Western Galilee Hospital - Nahariya
Nahariya, Israel, 22100
Rabin Medical Center
Petach Tikva, Israel, 49103
The Chaim Sheba Medical Center
Ramat-Gan, Israel, 5266202
Kaplan Medical Center
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Italy
Universita Di Bologna
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy, 50139
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, Italy, 47014
AORN "A. Cardarelli"
Napoli, Italy, 80131
Azienda Ospedaliero Universitaria di Parma
Parma, Italy, 43126
Ospedale S. Eugenio
Roma, Italy, 00144
Azienda Ospedaliera S. Maria di Terni
Terni, Italy, 05100
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Japan
Aichi, Japan, 460-0001
Aichi, Japan, 467-8602
Chiba-shi, Japan, 260-0856
Fukuoka, Japan, 811-1395
Higashiibaraki, Japan, 311-3193
Hiroshima, Japan, 7200001
Hokkaido, Japan, 060-8543
Kawagoe-city, Japan, 350-8550
Kawagoe, Japan, 150-8935
Maebashi City, Japan, 371-8511
Narita-shi, Japan, 286-8523
Niigata city, Japan, 951-8566
Okayama, Japan, 701-1192
Osaka, Japan, 543-8555
Sagamihara-city, Japan, 252-0375
Shibukawa-city, Japan, 377-0280
Shinjuku-ku, Japan, 1608582
Tokushima, Japan, 770-8539
Utsunomiya city, Japan, 320-0834
Korea, Republic of
Gachon University Gil Hospital
Incheon, Korea, Republic of, 405760
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Netherlands
VU Medisch Centrum
Amsterdam, Netherlands, 1081 HV
AMC
Amsterdam, Netherlands, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
UMC Utrecht
Utrecht, Netherlands, 3584 CX
New Zealand
North Shore Hospital
Auckland, New Zealand, 0620
Auckland City Hospital
Auckland, New Zealand, 1023
Canterbury Health Laboratories
Christchurch, New Zealand, 8011
Waikato Hospital
Hamilton, New Zealand, 3240
Middlemore Hospital
Otahuhu, New Zealand, 1640
Palmerston North Hospital
Palmerston North, New Zealand, 4414
Wellington Hospital
Wellington South, New Zealand, 6021
Poland
Szpital Specjalistyczny w Brzozowie
Brzozow, Poland, 36-200
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzow, Poland, 41-500
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Centrum Onkologii Ziemi Lubelskiej
Lublin, Poland, 20-081
Portugal
Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, Portugal, 3000-076
Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
Porto, Portugal, 4200-072
Romania
MedLife - PDR
Brasov, Romania, 500152
"Coltea" Clinical Hospital
Bucharest, Romania, 030171
Emergency University Hospital
Bucharest, Romania, 050098
Russian Federation
State Medical Preventive Healthcare Institution Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russian Federation, 454076
Hematology Research Center of RAMN
Moscow, Russian Federation, 125167
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
Nizhniy Novgorod, Russian Federation, 603126
Ryazan Regional Clinical Hospital
Ryazan, Russian Federation, 390039
Research Institute of Hematology and Blood Transfusion
St. Petersburg, Russian Federation, 193024
City Clinical Hospital #31
St. Petersburg, Russian Federation, 197110
Heart, Blood and Endocrinology Federal Center n.a. V.A. Almazov
St. Petersburg, Russian Federation, 197341
Volgograd Regional Oncology Center #1
Volgograd, Russian Federation, 400138
Singapore
National University Hospital
Singapore, Singapore, 119228
Singapore General Hospital
Singapore, Singapore, 169608
Spain
Hospital Costa del Sol
Marbella, Andalucia, Spain, 29600
Hospital Universitario de Salamanca
Salamanca, Castilla Y Leon, Spain, 37007
Hospital Clinic de Barcelona
Barcelona, Cataluna, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Cataluna, Spain, 08041
Hospital General Universitario Gregorio Maranon
Madrid, Madrid, Communidad De, Spain, 28007
Hospital Donostia
San Sebastian, Pais Vasco, Spain, 20014
Sweden
Sahlgrenska Universitetssjukhuset
Goteborg, Sweden, 41345
Skanes Universitetssjukhus- Lund
Lund, Sweden, 22185
Karolinska Universitetssjukhuset i Huddinge
Stockholm, Sweden, 14186
Karolinska universitetssjukhuset Solna
Stockholm, Sweden, 17164
Turkey
Ankara University Medical Faculty Cebeci Hospital
Ankara, Turkey, 06590
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, M204BX
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Singleton Hospital
Swansea, United Kingdom, SA2 8QA
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01564537     History of Changes
Other Study ID Numbers: C16010
2011-005496-17 ( EudraCT Number )
CTR20130908 ( Registry Identifier: SFDA CTR )
U1111-1164-7646 ( Registry Identifier: WHO )
NL40132.018.12 ( Registry Identifier: CCMO )
12/LO/0949 ( Registry Identifier: NRES )
JapicCTI-132345 ( Registry Identifier: JapicCTI )
1015042370 ( Registry Identifier: TCTIN )
C16010CTIL ( Registry Identifier: Israel )
First Posted: March 28, 2012    Key Record Dates
Results First Posted: January 27, 2016
Last Update Posted: October 15, 2018
Last Verified: October 2018

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug therapy

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
Lenalidomide
Ixazomib
Thalidomide
BB 1101
Glycine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists