Observational study of NINLARO® in Chinese adults with multiple myeloma

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

This study is testing how well ixazomib works and what side effects it causes in Chinese adults with multiple myeloma who are switching from other treatments.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Takeda (industry)
• Drugs / interventions: chemotherapy, cyclophosphamide, doxorubicin
• Locations: 12 sites (Hefei, Anhui and 11 other locations)
• Trial ID: NCT05013190 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the side effects and outcomes in adults with multiple myeloma who switch from bortezomib or carfilzomib-based treatments to an ixazomib-based regimen. Participants will be treated with ixazomib until disease progression or unacceptable toxicity, for a maximum of 26 cycles over 24 months. The study will enroll approximately 160 participants and will collect data prospectively from medical charts and electronic case report forms. Follow-up will occur every three months during the study period.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with multiple myeloma who have previously received bortezomib or carfilzomib-based treatments and are either transplant ineligible or not expecting to undergo transplant for at least 24 months.

Not a fit: Patients who have not been treated with bortezomib or carfilzomib-based regimens or those who are currently eligible for transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and effectiveness of ixazomib for patients with multiple myeloma who have previously been treated with other therapies.

How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating treatment transitions in multiple myeloma, suggesting potential for valuable insights.

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.

Where this trial is running

Hefei, Anhui and 11 other locations

• Anhui Cancer Hospital — Hefei, Anhui, China (RECRUITING)
• Beijing Chao-Yang Hospital,Capital Medical University — Beijing, Beijing, China (RECRUITING)
• Beijing Jishuitan Hospital — Beijing, Beijing, China (RECRUITING)
• Henan Province People Hospital — Zhengzhou, Henan, China (RECRUITING)
• The First Affiliated Hospital of Zhenzhou University — Zhengzhou, Henan, China (RECRUITING)
• Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia Autonomous Region, China (RECRUITING)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• Shengjing Hospital affiliated to China Medical University — Shenyang, Liaoning, China (RECRUITING)
• Qingdao Municipal Hospital — Qingdao, Qingdao, China (RECRUITING)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)
• Tianjin Medical University General Hospital — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Takeda Contact

Conditions: Multiple Myeloma, Drug Therapy