Clinical trial NCT05013190: A Study of NINLARO® in Chinese Adults With Multiple Myeloma
Official title: Clinical Outcome of Ixazomib (NINLARO®) Based Regimens in Chinese Patients With Multiple Myeloma Previously Receiving a Bortezomib/Carfilzomib-Based (re)Induction Regimen in Clinical Setting of Real World: An Open-Label, Single-Arm, Multicenter, Observation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been first diagnosed with MM and FRMM using IMWG criteria, and who have received a bortezomib/carfilzomib-based triple-drug regimens (more than 2 cycles) as initial therapy, and must achieve at least PR as defined by IMWG criteria at the time of enrollment will be included in this study.

Brief summary: The main aim of this study is to check side effects and results in adults with multiple myeloma after switching from a bortezomib/carfilzomib -based to an Ixazomib-based treatment.

Detailed description: This is a non-interventional, prospective study of participants with multiple myeloma (MM). Participants will be treated with ixazomib based regimens until progression or unacceptable toxicity leading to a discontinuation or change in regimen, for a maximum of 26 cycles (24 months) (as per NINLARO® label) in real world clinical setting.

The study will enroll approximately 160 participants. The data will be collected prospectively in medical charts and will be recorded into electronic case report forms (eCRFs). All the participants will be assigned to a single observational cohort:

• Participants with MM

This multi-center trial will be conducted in China. The overall time for data collection in the study will be 24 months. Participants will be followed once every 3 months unless withdraw of informed consent form, death or lost to follow-up, termination of the study by the sponsor, whichever comes first.

Eligibility criteria: Inclusion Criteria:

1. Who was first diagnosed or first relapse MM participants using IMWG 2016 criteria.
2. Diagnosed with multiple myeloma using IMWG 2016 criteria and must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment.

   o Stem cell harvest and mobilization regimen is acceptable if clinically indicated. But must first be confirmed by the Takeda Medical Monitor.
3. Who received bortezomib/carfilzomib-based triple-drug regimens as frontline treatment, including bortezomib+cyclophosphamide+dexamethasone (VCD), bortezomib+lenalidomide dexamethasone (VRD), bortezomib+doxorubicin+dexamethasone (PAD), bortezomib+thalidomide+dexamethasone (VTD), bortezomib+pomadomide+dexamethasone (VPD), or carfilzomib+lenalidomide+dexamethasone (KRD), carfilzomib+thalidomide+dexamethasone (KTD), carfilzomib+pomalidomide+dexamethasone (KPD).
4. Must achieve partial response (PR) as defined by IMWG 2016 criteria after bortezomib/carfilzomib-based initial therapy.
5. Eastern Cooperative Oncology Group (ECOG) 0-2.

Exclusion Criteria:

1. Received a bortezomib/carfilzomib-based triple-drug regimens as initial therapy less than 2 cycles.
2. Failure to have fully recovered (that is, less than or equal to \[\<=\] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
3. Have documented diagnosis of other cancers prior to the diagnosis of MM, excluding squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, which is considered cured with minimal risk of recurrence within 3 years.
4. Has \>=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinical examination at the time of enrollment.
5. Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
6. Have gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
7. Have an active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.

Primary outcomes:
measure: Progression Free Survival (PFS) at 24 Months
timeFrame: From the date of first administration of ixazomib therapy to the date of first documentation of PD or death, lost to follow-up, whichever occurs first (up to 24 months)
Secondary outcomes:
measure: Time to Next Treatment (TTNT)
timeFrame: From the date of the first administration of ixazomib therapy to first dose of new treatment (up to 24 months)
measure: Percentage of Participants Achieving Very Good Partial Response (VGPR)
timeFrame: Up to 24 months
measure: Percentage of Participants Achieving Complete Response (CR)
timeFrame: Up to 24 months
measure: Percentage of Participants Achieving Stringent Complete Response (sCR)
timeFrame: Up to 24 months
measure: Duration of Ixazomib Therapy (DOT)
timeFrame: Up to 24 months
measure: Duration of CR
timeFrame: Up to 24 months
measure: Overall Survival (OS)
timeFrame: Up to 24 months
measure: Health-related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC QLQ-MY20)
timeFrame: Up to 24 months
measure: HRQOL Based on EORTC QLQ-C30
timeFrame: Up to 24 months
measure: Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: Up to 24 months
measure: Number of Participants Categorized Based on Healthcare Resource Utilization
timeFrame: Up to 24 months
measure: Number of Participants Categorized Based on Reason for Dose Reduction of Ixazomib Therapy
timeFrame: Up to 24 months
measure: Number of Participants Categorized Based on Reason for Interruption of Ixazomib Therapy
timeFrame: Up to 24 months
measure: Number of Participants Categorized Based on Reason for Discontinuation of Ixazomib Therapy
timeFrame: Up to 24 months
measure: Relative Dose Intensity (RDI)
timeFrame: Up to 24 months
measure: Number of Participants who Experience at Least one Adverse Event (AE)
timeFrame: Up to 24 months
measure: Number of Participants Categorized Based on Occurrence of Second Primary Malignancies (SPM)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Province People Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhenzhou University
state: Henan
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia Autonomous Region
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Liaoning
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Qingdao
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: