Clinical Study on the Efficacy and Safety of MVRd Regimen in the Treatment of Newly Diagnosed Multiple Myeloma with Extramedullary Disease (EMD)

Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Combined with Bortezomib, Lenalidomide, and Dexamethasone (VRd) in Newly Diagnosed Multiple Myeloma Patients with Extramedullary Disease (EMD): A Prospective Single-Arm, Single-Center Clinical Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600124493

Enrollment

Unknown

Registered

2026-05-13

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed multiple myeloma with extramedullary disease

Interventions

Test group:Mitoxantrone Hydrochloride Liposome, Bortezomib, Lenalidomide, Dexamethasone

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects fully understand the study, voluntarily participate, and sign the Informed Consent Form (ICF); 2. Aged 18–75 years, regardless of gender; 3. ECOG performance status score of 0–2, with an expected survival of >= 3 months; 4. Diagnosed with multiple myeloma (MM) complicated by extramedullary disease (EMD): Extramedullary disease includes parosseous or extramedullary soft tissue masses (confirmed by pathology), with measurable lesions (longest diameter >= 1.5 cm) on computed tomography (CT) or other imaging modalities; 5. New York Heart Association (NYHA) functional classification of 0–2; 6. Laboratory test results meeting the following criteria: Total Bilirubin (TBIL) <= 1.5 × upper limit of normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <= 2.5 × upper limit of normal (ULN);

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of severe allergy to any drug in the regimen (Mitoxantrone Hydrochloride Liposome, Bortezomib, Lenalidomide); 2. Subjects with intolerance to any drug in the regimen; 3. Subjects with severe infection; 4. Subjects with severe heart disease or cardiac insufficiency, or complicated with cardiac amyloidosis, and judged by the investigator to be unable to use anthracycline drugs; or subjects who have previously received a large dose of anthracycline drugs for other diseases and cannot continue to receive the full dose as specified in the study protocol; 5. Subjects with grade >= 3 peripheral neuropathy (from any cause) at initial diagnosis, and judged by the investigator to be unsuitable for Bortezomib use; 6. Other conditions judged by the investigator to make subjects unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
Objective Response Rate;Duration of Response;Safety indicators;	—

Secondary

Measure	Time frame
Progression free survival (PFS);changes of patients' quality of life;	—

Countries

China

Contacts

Public ContactMeng Shan

Xi'an Jiaotong University Second Affiliated Hospital

101xyz2@163.com+86 29 8767 9459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026