The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT02844322
Phase
PHASE4
Status
Completed

Conditions

  • Waldenström Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia
  • Rituximab — DRUG
    compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Study Details

The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.

Key Dates

Start date
May 31, 2016
Status verified
Mar 2024
Primary completion
May 31, 2022
Completion
May 31, 2023

Study Design

Enrollment
35 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bortezomib
    Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.
  • Experimental: rituximab
    Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a MR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a MR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study.

Primary Outcome Measure

progress-free survival [ Time Frame: up to 36 months ]

Related Studies