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VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma

NCT03641456 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-06-18

No results posted yet for this study

Summary

The phase 2 study evaluated the efficacy and safety of bortezomib in combination with lenalidomide as maintenance therapy in high risk newly diagnosed multiple myeloma patients who receive lenalidomide,bortezomib, and dexamethasone Combination as induction therapy.

Conditions

  • Myeloma
  • Newly Diagnosed
  • High Risk

Interventions

DRUG

bortezomib

The investigators gave patients subcutaneous bortezomib 1.3mg/m2 on days 1, 8,15, and 22 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.Responding patients could receive maintenance therapy comprising 4-week cycles of bortezomib on days 1 and 15 at the dose level of 1.3mg/m2. Patients discontinued treatment if they had progressive disease or or unacceptable toxic effects not controlled with dose modifications.

DRUG

Lenalidomide

The investigators gave patients oral lenalidomide 25mg on days 1 to 21 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.Responding patients could receive maintenance therapy comprising 4-week cycles of lenalidomide on days 1 to 21 at the dose level of 10mg. Patients discontinued treatment if they had progressive disease or unacceptable toxic effects not controlled with dose modifications.

DRUG

Dexamethasone

The investigators gave patients oral dexamethasone 40mg on days 1, 8, 15 and 22 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hua Wang, MD. · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03641456 on ClinicalTrials.gov