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The efficacy of Bortezomib with lenalidomide and dexamethasone (VRd) in newly diagnosised multiple myeloma and screening for associated biomarkers

The efficacy of Bortezomib with lenalidomide and dexamethasone (VRd) in newly diagnosised multiple myeloma and screening for associated biomarkers:a prospective, multi-center, single-arm clinical trial.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039966
Enrollment
Unknown
Registered
2020-11-15
Start date
2020-11-02
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

multiple myeloma

Interventions

singal arm:VRd regmen

Sponsors

Department of Hematology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Adult male or female patients aged 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria. (NCCN 2020.V3) 2. Patient is willing and able to adhere to the study visit schedule(including blood sampling and bone marrow aspiration). 3. Blood routine: absolute neutrophil count (ANC)>= 1.0*10^9/L,platelet count >= 75*10^9/L. Biochemical examination: total bilirubin = 30mL/min (using the Cockroft-Gault equation) 4. Eastern Cooperative Oncology Group Performance Status of 0 to 2.

Exclusion criteria

Exclusion criteria: 1. Ongoing or active infection, known human immunodeficiency virus positive, active hepatitis B or C infection. 2. Psychiatric illness/social situation that would limit compliance with study requirements.Allergy to the study medications, 3. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, 4. Diagnosis of smodering multiple myeloma, Waldenstroms macroglobulinemia, plasma cell leukemia, POEMS syndrome myelodysplastic syndrome. 5. Cardiac color ultrasound suggests severe pulmonary hypertension (mAP >= 40mmHg), New York Heart association (NYHA) functional class III and above. 6. Diagnosed for another malignancy within 1 year before diagnosis of multiple myeloma; 7. Female patient who is lactating and breastfeeding or has a positive serum pregnancy test during the screening period. 8. Unable to cooperate with or not suitable for PET/CT examination; 9. Acute or sub-acute deep venous thrombosis within 2 weeks. 10. Grade II and above peripheral neuropathy.

Design outcomes

Primary

MeasureTime frame
objective remission rate;

Countries

China

Contacts

Public ContactLu Zhong

Renji Hospital, School of Medicine, Shanghai Jiao Tong University,

lucyzg25@126.com+86 13817870510

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026