A Study of NINLARO® in Chinese Adults With Multiple Myeloma

NCT05013190 | Active Not Recruiting FDA Drug

• 1 other identifier: C15058
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 12

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.

Conditions

Multiple Myeloma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) at 24 Months

  PFS:time date of first administration of ixazomib therapy to date of first documentation of progressive disease(PD)/death,lost to follow-up,whichever occurs first as per IMWG 2016 Response Criteria.PD:increase of 25 percent(%) from lowest confirmed response value in any one/more of following:Serum and Urine M-protein only in participants without measurable serum and urine M-protein levels,difference between involved/uninvolved free light chain (FLC) levels(absolute increase greater than(\>)10 milligram per deciliter \[mg/dL\]),and without measurable involved FLC levels, bone marrow plasma-cell% irrespective of baseline status (absolute increase must be ≥10%); appearance of new lesions, ≥50% increase from nadir in SPD of \>1 lesion/ ≥50% increase in the longest diameter of a previous lesion \>1 centimeter in short axis; ≥50% increase in circulating plasma cells (minimum of 200 cells per microliter \[mcL\]) if this is the only measure of disease. It will be analyzed using Kaplan-Meier method.

  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 (17)

• Time to Next Treatment (TTNT)

  From the date of the first administration of ixazomib therapy to first dose of new treatment (up to 24 months)

• Percentage of Participants Achieving Very Good Partial Response (VGPR)

  Up to 24 months

• Percentage of Participants Achieving Complete Response (CR)

  Up to 24 months

• Percentage of Participants Achieving Stringent Complete Response (sCR)

  Up to 24 months

• Duration of Ixazomib Therapy (DOT)

  Up to 24 months

Study Arms (1)

Participants With Multiple Myeloma (MM)

Participants diagnosed with MM (newly diagnosed multiple myeloma \[NDMM\] and first relapse multiple myeloma \[FRMM\]) using International Myeloma Working Group (IMWG) criteria who received a bortezomib/carfilzomib-based triple-drug regimens for more than 2 cycles as initial therapy, achieved at least partial response (PR) as defined by IMWG criteria, and are ready to start receiving an ixazomib containing therapy prescribed by their treating physician will be observed prospectively for 24 months.

Other: No intervention

Interventions

No intervention OTHER

This is a non-interventional study.

Participants With Multiple Myeloma (MM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Who was first diagnosed or first relapse MM participants using IMWG 2016 criteria.
• 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.
• a. Stem cell harvest and mobilization regimen is acceptable if clinically indicated. But must first be confirmed by the Takeda Medical Monitor.
• 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).
• Must achieve at least partial response (PR) as defined by IMWG criteria after bortezomib/carfilzomib-based initial therapy.
• Eastern Cooperative Oncology Group (ECOG) 0-2.

You may not qualify if:

• Received a bortezomib/carfilzomib-based triple-drug regimens as initial therapy less than 2 cycles.
• Failure to have fully recovered (that is, less than or equal to \[\<=\] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
• 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.
• Has \>=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinical examination at the time of enrollment.
• Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not.
• Have gastrointestinal (GI) disease or procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
• Have an active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.

Sponsors & Collaborators

• Takeda: lead

Study Sites (12)

Anhui Cancer Hospital

Hefei, Anhui, 230000, China

Location

Beijing Chao-Yang Hospital,Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100096, China

Location

Henan Province People Hospital

Zhengzhou, Henan, 450004, China

Location

The First Affiliated Hospital of Zhenzhou University

Zhengzhou, Henan, 450052, China

Location

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010050, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110022, China

Location

Qingdao Municipal Hospital

Qingdao, Qingdao, 266071, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Related Publications (1)

• Chen W, Liu A, Li L. The MODIFY Study Protocol: An Open-Label, Single-Arm, Multicenter, Prospective Pragmatic Study of Ixazomib-Based Triple-Drug Therapy in Chinese Patients with Multiple Myeloma. Adv Ther. 2023 Feb;40(2):705-717. doi: 10.1007/s12325-022-02355-3. Epub 2022 Dec 4.

  PMID: 36463561 DERIVED

Related Links

• To obtain more information on the study, click on this link.

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 19, 2021
• Study Start: October 29, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (12)