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Trial record 1 of 1 for:    C16011
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Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Takeda ( Millennium Pharmaceuticals, Inc. )
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT01659658
First received: August 2, 2012
Last updated: June 8, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.

Condition Intervention Phase
Relapsed or Refractory Systemic Light Chain Amyloidosis Drug: IXAZOMIB Drug: Dexamethasone Drug: Melphalan Drug: Cyclophosphamide Drug: Thalidomide Drug: Lenalidomide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage Of Participants With Overall Hematologic Response [ Time Frame: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death which occurs first (approximately 9.3 years) ]
    Overall Hematologic Response was defined as the percentage of participants with Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) based on central laboratory results and the 2010 International Society of Amyloidosis (ISA) Consensus Criteria as assessed by an Adjudication Committee. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of Free Light Chain (FLC) ratio. VGPR: Differential Free Light Chain (difference between involved and uninvolved FLC levels; dFLC) < 40 mg/L. PR: ≥50% reduction in dFLC.

  • 2-Year Vital Organ (Heart Or Kidney) Deterioration And Mortality Rate [ Time Frame: Monthly or until death (Up to 2 years) ]
    Cardiac (Heart) deterioration is defined as the need for hospitalization for heart failure. Kidney deterioration is defined as progression to end-stage renal disease (ESRD) with the need for maintenance dialysis or renal transplantation. Vital organ deterioration will be evaluated by an Adjudication Committee.


Secondary Outcome Measures:
  • Percentage Of Participants With Complete Hematologic Response [ Time Frame: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (approximately 9.3 years) ]
    Complete Hematologic Response was defined as the percentage of participants with CR based on central laboratory results and the 2010 ISA Consensus Criteria as assessed by an Adjudication Committee. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of FLC ratio.

  • Overall Survival [ Time Frame: From the date of randomization until death (approximately 9.3 years) ]
    Overall survival is defined as the time from the date of randomization to the date of death.

  • Progression Free Survival (PFS) [ Time Frame: From date of randomization until discontinuation of study drug due to disease progression or unacceptable toxicity, or death which occurs first (approximately 9.3 years) ]
    PFS is defined as the time from the date of randomization to the date of first documentation of hematologic disease progression, or organ (cardiac or renal) progression, or death due to any cause, whichever occurs first according to central laboratory results and ISA criteria as evaluated by an Adjudication Committee.

  • Hematologic Disease Progression Free Survival [ Time Frame: From date of randomization until discontinuation of study drug due to disease progression or unacceptable toxicity, or death which occurs first (approximately 9.3 years) ]
    Hematologic disease PFS is defined as the time from the date of randomization to the date of first documentation of hematologic PD according to central laboratory results and ISA criteria as evaluated by an Adjudication Committee, or death due to any cause, whichever occurs first.

  • Time To Vital Organ (Heart Or Kidney) Deterioration And Mortality Rate [ Time Frame: From randomization to time of vital organ deterioration or death (approximately 9.3 years) ]
    Time to vital organ deterioration or death defined as the time from randomization to vital organ (heart or kidney) deterioration or death, whichever occurs first. Cardiac deterioration is defined as the need for hospitalization for heart failure. Kidney deterioration is defined as progression to ESRD with the need for maintenance dialysis or renal transplantation.

  • Percentage Of Participants With Best Vital Organ (Cardiac And/Or Kidney) Response [ Time Frame: From randomization until discontinuation of study drug due to disease progression or unacceptable toxicity, or death which occurs first (approximately 9.3 years) ]
    Vital organ (heart and kidney) response rate is defined as the percentage of participants who achieved vital organ response according to central laboratory results and ISA criteria as evaluated by an Adjudication Committee. A vital organ response is defined as response of 1 or 2 of the involved vital organs with no change from Baseline in the rest of involved vital organs.

  • Vital Organ Progression Free Survival [ Time Frame: From randomization until discontinuation of study drug due to disease progression or unacceptable toxicity, or death which occurs first (approximately 9.3 years) ]
    Vital organ PFS is defined as the time from the date of randomization to the date of first documentation of progression of vital organ (heart or kidney) according to central laboratory results and ISA criteria as evaluated by an Adjudication Committee, or death due to any cause, whichever occurs first.

  • Duration of Hematologic Response [ Time Frame: From time of first documented response to disease progression (up to 9.3 years) ]
    Duration of hematologic response (DOR) is defined as the time from the date of first documentation of a hematologic response to the date of first documented hematologic disease progression according to central laboratory results and ISA criteria as determined by an Adjudication Committee.

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of study drug through 30 days after administration of the last dose of study drug (approximately 9.3 years) ]
    An Adverse Event (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.

  • Time To Treatment Failure (TTF) [ Time Frame: From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (approximately 9.3 years) ]
    TTF is defined as the time from randomization to the date of first documented treatment failure. Treatment failure is defined as: 1) death due to any cause; 2) hematologic progression or major organ progression according to central laboratory results and ISA criteria as evaluated by an Adjudication Committee; 3) clinically morbid organ disease requiring additional therapy; or 4) withdrawn for any reason.

  • Time To Subsequent Anticancer Treatment [ Time Frame: From first dose of study drug until subsequent anticancer treatment (up to 9.3 years) ]
    Time to subsequent anticancer therapy is defined as the time from randomization to the first date of subsequent anticancer therapy. Participants without subsequent anticancer therapy will be censored at the date of death or last known to be alive.

  • Change From Baseline In SF-36 General Health Survey Score [ Time Frame: At screening (Baseline); Cycle 1, Day 1; Cycle 3, Day 1; Day 1 of every 3 cycles until disease progression (approximately 9.3 years) ]
    SF-36 v2 is a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8- scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). The sub-score scale ranges from 0 (best) to 100 (worst). A negative change from Baseline indicates improvement.

  • Change From Baseline In Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Score [ Time Frame: At screening (Baseline); Cycle 1, Day 1; Cycle 2, Day 1;Cycle 3, Day 1; Day 1 of every 3 cycles until disease progression (approximately 9.3 years ]
    The FACT/GOG-Ntx is a participant completed questionnaire that comprises 11 individual items evaluating symptoms of neurotoxicity on a 5-point scale where: 0 =not at all (best) to 4=very much for a total possible score of 0 to 44. A negative change from Baseline indicates improvement.

  • Change From Baseline In Amyloidosis Symptom Scale Score [ Time Frame: At screening (Baseline); Cycle 1, Day 1; Cycle 2, Day 1;Cycle 3, Day 1; Day 1 of every 3 cycles until disease progression (approximately 9.3 years ]
    The Amyloidosis symptom scale questionnaire is a participant completed questionnaire that evaluates symptom severity of 3 symptoms: Swelling, Shortness of Breath and Dizziness, each rated on an 11-point scale where: 0 =No symptoms to 10=very severe symptoms. A negative change from Baseline indicates improvement.

  • EuroQol 5-Dimensional (EQ-5D) Questionnaire Score [ Time Frame: At screening; Cycle 1, Day 1; Cycle 2, Day 1; Cycle 3, Day 1; Day 1 of every 3 cycles until disease progression(approximately 9.3 years ]
    The European Quality of Life (EuroQOL) 5-Dimensional (EQ-5D) is a patient completed questionnaire consisting of 2 pages: the EQ-5D descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 3 possible choices: no problems to extreme problems. The EQ visual analogue scale (VAS) records the participant's self-rated health on a 20 centimeter vertical VAS that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

  • Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for IXAZOMIB and its metabolite MLN2238 [ Time Frame: Cycle 1, Day 1 at multiple time points (up to 4 hours) postdose and Day 14 at any time; Cycle 2, Day 1 predose and Day 14 at any time; Cycles 3-10 predose ]
    Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

  • Number of Medical Encounters Participant Experiences [ Time Frame: At screening; Cycle 1, Day 1; Cycle 2, Day 1; Cycle 3, Day 1; Day 1 of every 3 cycles until disease progression (approximately 9.3 years) ]
    Medical encounters will be recorded as the number of admissions to an inpatient and outpatient setting for any reason (including length of stay, inpatient, outpatient and reason), number of missing days from work or other activities by participant or care-giver.


Estimated Enrollment: 248
Actual Study Start Date: December 26, 2012
Estimated Study Completion Date: September 1, 2018
Estimated Primary Completion Date: September 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IXAZOMIB 4 mg + Dexamethasone 20 mg/day
IXAZOMIB 4 mg, capsules, orally, once on Days 1, 8, and 15; plus dexamethasone 20 mg/day, orally, weekly on Days 1, 8, 15, and 22 of each 28-day cycle; dexamethasone may be increased up to 40 mg/day after 4 weeks, if tolerated. Participants may continue to receive treatment until Progressive Disease (PD) or unacceptable toxicity, whichever comes first.
Drug: IXAZOMIB
IXAZOMIB capsules
Other Name: MLN9708
Drug: Dexamethasone
Dexamethasone tablets
Active Comparator: Physician's Choice

Participants will receive one of the following treatment options as selected by the physician:

  • Dexamethasone 20 mg/day: dexamethasone 20 mg/day, orally, on Days 1-4, 9-12 and 17- 20 of each 28-day cycle.
  • Dexamethasone 20 mg/day + Melphalan 0.22 mg/kg: dexamethasone 20 mg/day, orally, on Days 1-4 of each 28-day cycle; plus melphalan 0.22 mg/kg, orally, on Days 1-4 every 28 days.
  • Dexamethasone 20 mg/day + Cyclophosphamide 500 mg: dexamethasone 20 mg/day, orally, weekly on Days 1, 8, 15 and 22 of each 28-day cycle; plus cyclophosphamide 500 mg, orally, on Days 1, 8 and 15 every 28 days.
  • Dexamethasone 20 mg/day + Thalidomide 200 mg/day: dexamethasone 20 mg/day, orally, weekly Days 1, 8, 15 and 22 of each 28-day cycle; plus thalidomide total dose up to 200 mg/day, orally.
  • Dexamethasone 20 mg/day+ Lenalidomide 15 mg/day: dexamethasone 20 mg/day, orally, weekly on Days 1, 8, 15 and 22 of each 28-day cycle; plus lenalidomide 15 mg/day, orally, for 21 days every 28 days.
Drug: Dexamethasone
Dexamethasone tablets
Drug: Melphalan
Melphalan tablets
Drug: Cyclophosphamide
Cyclophosphamide tablets
Drug: Thalidomide
Thalidomide capsules
Drug: Lenalidomide
Lenalidomide capsules

Detailed Description:

The drug being tested in this study is called IXAZOMIB. IXAZOMIB was being tested to treat people who have relapsed or Refractory Systemic Light Chain (AL) Amyloidosis.

The study will enroll approximately 248 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

  • IXAZOMIB 4 mg plus Dexamethasone 20 mg
  • Physician's choice: Participants will receive one of the following treatment options as selected by the physician:

    1. Dexamethasone 20 mg
    2. Dexamethasone 20 mg + Melphalan 0.22 mg/kg
    3. Dexamethasone 20 mg + Cyclophosphamide 500 mg
    4. Dexamethasone 20 mg + Thalidomide 200 mg
    5. Dexamethasone 20 mg + Lenalidomide 15 mg
    6. All participants will be asked to take oral formulation of the drugs. In both treatment arms, each participant will continue to receive sequential cycles of therapy until disease progression, unacceptable toxicity, or until the study is terminated, whichever occurs first. Participants in Arm B receiving melphalan and dexamethasone will be treated to best response plus 2 additional cycles.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 112 months (9.3 years), including 84 months of enrollment and 28 months of follow-up after the last participant is enrolled.

  Eligibility

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

Inclusion Criteria:

  1. Male or female participants 18 years or older.
  2. Biopsy-proven diagnosis of primary systemic light chain amyloidosis (AL amyloidosis) according to the following standard criteria:

    1. Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence
    2. If clinical and laboratory parameters insufficient to establish AL amyloidosis or in cases of doubt, amyloid typing may be necessary.
  3. Measurable disease as defined by serum differential free light chain concentration (dFLC, difference between amyloid forming [involved] and nonamyloid forming [uninvolved] free light chain [FLC]) ≥ 50 mg/L.
  4. Objective, measurable major (cardiac or renal) organ amyloid involvement as defined as follows (amyloid involvement of at least 1 required):

    1. Cardiac involvement is defined as the presence of a mean left ventricular wall thickness on echocardiogram greater than 12 mm in the absence of other potential causes of left ventricular hypertrophy (controlled hypertension is allowed) with a noncardiac biopsy showing amyloid, or a positive cardiac biopsy in the presence of clinical or laboratory evidence of involvement. If there is isolated cardiac involvement, then typing of amyloid deposits is recommended.
    2. Renal involvement is defined as proteinuria (predominantly albumin) >0.5 g/day in a 24-hour urine collection.

    Note: Amyloid involvement of other organ systems is allowed, but not required.

  5. Must be relapsed or refractory after 1 or 2 prior therapies. For this protocol, relapsed is defined as progressive disease (PD) documented more than 60 days after last dose; refractory is defined as documented absence of hematologic response or hematologic progression on or within 60 days after last dose of prior therapy.

    1. Participant must not have been previously treated with proteasome inhibitors. (The sponsor reserves the right to open the study to proteasome inhibitor-exposed participants in the future, at some time point after the first interim analysis (IA). In that case, the participant may not be refractory to proteasome inhibitor therapy.)
    2. Given that the physician may select from an offered list of regimens to treat a specific participant, the participant may be refractory to an agent/s listed within the list of offered treatment choices
    3. Must have recovered (ie, ≤ Grade 1 toxicity or participant's baseline status) from the reversible effects of prior therapy
    4. If a participant has received a transplant as his/her first-line therapy, he/she must be at least 3 months post transplantation and recovered from the side effects of the stem cell transplant.
  6. Must meet criteria for 1 of the following AL Amyloidosis Risk Stages (as defined by N-terminal proBNP [NT-proBNP] cut-off of < 332 pg/mL and troponin T cut-off of 0.035 ng/mL as thresholds):

    1. Stage 1: both NT-proBNP and troponin T under threshold
    2. Stage 2: either NT-proBNP or troponin T (but not both) over threshold;
    3. Stage 3: both NT-proBNP and troponin T over threshold (but NT-proBNP < 8000 pg/mL)
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
  8. Clinical laboratory values:

    1. Absolute neutrophil count ≥ 1000/µL
    2. Platelet count ≥ 75,000/µL
    3. Total bilirubin ≤ 1.5 upper limit of normal (ULN), except for participants with Gilbert's syndrome as defined by > 80% unconjugated bilirubin and total bilirubin ≤ 6 mg/dL
    4. Alkaline phosphatase ≤ 5 x ULN
    5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 x ULN
    6. Calculated creatinine clearance ≥ 30 mL/min
  9. Female participants who:

    1. If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study treatment, AND
    2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
    3. Agree to practice true abstinence when this is line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.).

    Male participants, even if surgically sterilized (ie, status post vasectomy), who:

    1. Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, AND
    2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
    3. Agree to practice true abstinence when this is line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
  10. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

Exclusion Criteria:

  1. Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis.
  2. Female participants who are lactating, breast feeding, or pregnant.
  3. Medically documented cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, or severe orthostatic hypotension or clinically important autonomic disease.
  4. Clinically overt multiple myeloma, according to the International Myeloma Working Group (IMWG) criteria with at least 1 of the following:

    1. Bone lesions
    2. Hypercalcemia, defined as a calcium of > 11 mg/dL
  5. 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.
  6. Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered to be investigational or which would be considered as a treatment of AL amyloidosis. However, participants may be on chronic steroids (maximum dose 20 mg/day prednisone or equivalent) if they are being given for disorders other than amyloidosis (eg, adrenal insufficiency, rheumatoid arthritis, etc.).
  7. 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.
  8. Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.
  9. Psychiatric illness/social situations that would limit compliance with study requirements.
  10. Known allergy to boron, MLN9708, any of the study treatments, their analogues, or excipients.
  11. Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment.
  12. Diagnosed or treated for another malignancy within 3 years (5 years for sites in France) before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  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: NCT01659658

Contacts
Contact: Takeda Study Registration Call Center +1-844-662-8532 globaloncologymedinfo@takeda.com

  Hide Study Locations
Locations
United States, California
Cedars Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
United States, Illinois
University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 2118
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 211
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 5590
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110-1093
United States, New York
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0502
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
United States, Wisconsin
Froedtert and The Medical College of Wisconsin Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 214
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Brazil
Centro de Pesquisas Oncologicas Recruiting
Florianopolis, Santa Catarina, Brazil, 88034-000
Hospital Universitario Clementino Fraga Filho (UFRJ) Recruiting
Rio de Janeiro, Brazil, 21941-913
Irmandade Da Santa Casa de Misericordia de Sao Paulo Recruiting
Sao Paulo, Brazil, 01223-001
Hospital Israelita Albert Einstein Recruiting
Sao Paulo, Brazil, 05652-900
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 5403000
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G2M9
Czechia
Fakultni nemocnice Ostrava Recruiting
Ostrava, Moravskoslezsk kraj, Czechia, 708 52
Vseobecna fakultni nemocnice v Praze Recruiting
Praha, Praha, hlavni mesto, Czechia, 128 08
Denmark
Arhus Universitetshospital Arhus Sygehus Recruiting
Aahus, Denmark, 800
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
France
Hotel Dieu Recruiting
Nantes, Loire-Atlantique, France, 44093
Hopital Claude Huriez Recruiting
Lille, France, 5903
Centre Hospitalier et Universitaire de Limoges Recruiting
Limoges, France, 87042
Hopital Saint Louis Recruiting
Paris, France, 75010
Hopital de Rangueil Recruiting
Toulouse, France, 31059
Germany
Charite - Universitatsmedizin Berlin Recruiting
Berlin, Germany, 12200
Universitatsklinikum Hamburg Eppendorf Recruiting
Hamburg, Germany, 20246
Universitat Heidelberg Recruiting
Heidelberg, Germany, 69120
Greece
University General Hospital of Patras Recruiting
Patras, Achaia, Greece, 26500
Alexandra Hospital Recruiting
Athens, Greece, 11528
Israel
Rambam Health Corporation Recruiting
Haifa, Israel, 31096
Hadasit Medical Research Services and Development Ltd Recruiting
Jerusalem, Israel, 911
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Rabin Medical Center - PPDS Recruiting
Petach Tikva, Israel, 49100
Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Italy
Institute of Hematology "Seragnoli" University of Bologna Recruiting
Bologna, Italy, 40138
Fondazione IRCCS Policlinico San Matteo di Pavia Recruiting
Pavia, Italy, 2710
Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110744
Severance Hospital at Yonsei University Health System - PPDS Recruiting
Seoul, Korea, Republic of, 120-752
Samsung Medical Center - PPDS Recruiting
Seoul, Korea, Republic of, 135-710
The Catholic University of Korea, Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-70
Netherlands
VU Medisch Centrum Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Maastricht University Medical Center Recruiting
AZ Maastricht, Netherlands, 620
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3508
Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 8036
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Hospital Universitario Puerta de Hierro - Majadahonda Recruiting
Majadahonda, Spain, 28222
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B152TH
Royal Free and University College Medical School Recruiting
London, United Kingdom, NW3 2P
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, MI3 9WL
Oxford University Hospitals NHS Trust Active, not recruiting
Oxford, United Kingdom, OX3 7L
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Additional Information:
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01659658     History of Changes
Other Study ID Numbers: C16011
2011-005468-10 ( EudraCT Number )
U1111-1164-7621 ( Registry Identifier: WHO )
C16011-CTIL ( Other Identifier: Israel )
NL41603.028.12 ( Registry Identifier: CCMO )
Study First Received: August 2, 2012
Last Updated: June 8, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
MLN9708
Amyloidosis
Light Chain
IXAZOMIB
Tourmaline AL1
Drug Therapy

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone acetate
Dexamethasone
Lenalidomide
Ixazomib
Cyclophosphamide
Melphalan
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on August 22, 2017