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A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone

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ClinicalTrials.gov Identifier: NCT03433001
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (IRd) in patients with relapsed and/or refractory multiple myeloma (RRMM), under conditions of standard medical care. In addition, an exploratory study of biomarkers will be conducted.

Condition or disease Intervention/treatment
Relapsed and/or Refractory Multiple Myeloma Drug: Ixazomib Drug: Lenalidomide Drug: Dexamethasone

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) under the conditions of standard medical care. This study is a non-interventional (observational), domestic, multicenter, prospective study in patients with RRMM. This study will look at the effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone in Japanese patients with RRMM as standard medical care. In addition, an exploratory study of biomarkers will be conducted in this study.

The study will enroll approximately 300 patients. All participants will receive Ixazomib + Lenalidomide + Dexamethasone (IRd) therapy as standard medical care.

This multi-center trial will be conducted in Japan. The overall time of observational period in this study will be 36 months. For each participant, the observation period will be from the start of IRd therapy until either 24 months after the enrollment date of the final patient to enroll, or until death or withdrawal of consent, whichever is earlier.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Observational Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


Group/Cohort Intervention/treatment
Ixazomib + Lenalidomide + Dexamethasone
Participants will take ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone will not be defined by the protocol but according to the package insert of each drug.
Drug: Ixazomib
Ixazomib capsules

Drug: Lenalidomide
Lenalidomide capsules

Drug: Dexamethasone
Dexamethasone tablets




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to 36 Months as a maximum ]
    PFS is defined as is defined as the period from the start of IRd therapy in standard medical care to the time of confirmed progressive disease (PD) or confirmed death (regardless of the cause of death), whichever is earlier. PFS will be assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.


Secondary Outcome Measures :
  1. PFS Rate at 12 Months and 24 Months after the Start of Treatment [ Time Frame: 12 months and 24 months ]
    PFS is defined as is defined as the period from the start of IRd therapy in standard medical care to the time of confirmed PD or confirmed death (regardless of the cause of death), whichever is earlier. PFS will be assessed by IMWG Criteria.

  2. Overall Survival (OS) [ Time Frame: Up to 36 months as a maximum ]
    OS is defined as the period from the start of IRd therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed.

  3. Percentage of Participants who Achieve or Maintain Any Best Response [ Time Frame: Up to 36 months as a maximum ]
    Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), very good PR (VGPR) and complete response (CR) assessed with IMWG Criteria after each cycle of treatment. Per IMWG criteria, PR: ≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to <200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ ≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/ ≥50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ ≥90% reduction in serum M-protein+urine M-protein level <100 mg/24-hour. CR: negative immunofixation on serum+urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow.

  4. Time to Next Treatment (TTNT) [ Time Frame: Up to 36 months as a maximum ]
    TTNT will be measured as the period from the start of IRd therapy in standard medical care to the start of next treatment or time when death is confirmed (regardless of the cause of death), whichever is earlier.

  5. Duration of Therapy (DOT) [ Time Frame: Up to 36 months as a maximum ]
    DOT is defined as the treatment duration of IRd therapy.

  6. Percentage of Participants who Continue to Receive Treatment at 12 Months and 24 Months after Start of Treatment [ Time Frame: 12 months and 24 months ]
  7. Overall Response Rate (ORR) [ Time Frame: Up to 36 months as a maximum ]
    ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment.

  8. Percentage of Participants who Achieve VGPR or Better (CR+VGPR) [ Time Frame: Up to 36 months as a maximum ]
    The percentage of participants of CR + VGPR is defined as the rate of participants who achieve a best response of VGPR or better (sCR, CR, or VGPR) according to the IMWG Criteria after the start of the IRd therapy.

  9. Patient-Reported Outcome Health-Related Quality of Life (HRQoL) based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) [ Time Frame: Up to 36 months as a maximum ]
    EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=Very poor [worst] to 7= Excellent [best]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.

  10. Patient-Reported Outcome HRQoL based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score [ Time Frame: Up to 36 months as a maximum ]
    EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.

  11. Rate of Minimal Residual Disease (MRD) Negativity in Bone Marrow in Participants who Achieved CR [ Time Frame: Up to 36 months as a maximum ]
    Rate of MRD will be calculated by the percentage of participants who are MRD-negative.

  12. Relative Dose Intensity (RDI) [ Time Frame: Up to 36 months as a maximum ]
    RDI is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals [dose prescribed at enrollment* number of prescribed doses per cycle* the number of treated cycles].

  13. Percentage of Participants with Bone Lesions (Bone Evaluation) [ Time Frame: Up to 36 months as a maximum ]
  14. Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs) [ Time Frame: Up to 36 months as a maximum ]
    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. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of adult men and women who have a confirmed diagnosis of multiple myeloma, who is scheduled to begin treatment with IRd due to relapsed and/or refractory disease, and who meet other eligibility criteria.
Criteria

Inclusion Criteria:

  1. Men and women aged 20 years or older at the time of enrollment
  2. Patients with RRMM
  3. Participants who are scheduled to start IRd therapy
  4. Participants who can provide written informed consent of their own free will before the start of study treatment
  5. Participants who are judged by the principal investigator or investigator(s) to have the faculty to understand and comply with the requirements of the study

Exclusion Criteria:

  1. Female Participants who are nursing or pregnant
  2. Participants who have been treated with ixazomib
  3. Participants with hypersensitivity to any of the components of IRd therapy, their analogs or excipients
  4. Participants with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for participants with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment
  5. Participants who are not registered with, or comply with, the guidelines of the lenalidomide management program
  6. Participants who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study

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): NCT03433001


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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Japan
Takeda Selected Site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03433001     History of Changes
Other Study ID Numbers: C16042
JapicCTI-183860 ( Registry Identifier: JapicCTI )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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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
Dexamethasone acetate
Lenalidomide
Ixazomib
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