The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia

The Efficacy of Cyclophosphamide Plus Dexamethasone Combinated With Rituximab or Bortezomib for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Randomized Control Trial From China

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02844322

Acronym

BDH-WM01

Enrollment

Registered

2016-07-26

Start date

2016-05-01

Completion date

2023-05-01

Last updated

2026-02-11

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

Conditions

Waldenström Macroglobulinemia

Brief summary

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.

Detailed description

Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.

Interventions

DRUGBortezomib

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

DRUGRituximab

compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. aged \>=18 years 2. diagnosed with LPL/WM 3. untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib 4. symptom patients 5. with life-expectancy more than 3 months.

Exclusion criteria

1. diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma) 2. transformed lymphoma 3. liver or renal function lesion unrelated to lymphoma 4. serious complications such as uncontrolled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician 5. HIV positive or active HBV infection or other uncontrolled systematic infection 6. clinical central nervous dysfunction 7. serious surgery within 30 days 8. pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.

Design outcomes

Primary

Measure	Time frame
progress-free survival	up to 36 months

Secondary

Measure	Time frame
Overall response rate	up to 12 months

Countries

China

Contacts

PRINCIPAL_INVESTIGATORShuhua Yi, Doc

Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026