PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia
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ClinicalTrials.gov Identifier: NCT02971982 |
Recruitment Status : Unknown
Verified October 2016 by The First Affiliated Hospital of Soochow University.
Recruitment status was: Recruiting
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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Treatment | Drug: rituximab /Dexamethasone/cyclophosphamide Drug: Velcade/Dexamethasone/cyclophosphamide | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia |
Study Start Date : | October 2016 |
Estimated Primary Completion Date : | October 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
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Experimental: rituximab /Dex/CTX
rituximab /Dexamethasone/cyclophosphamide 6 cycles followed by rituximab (at least 2 cycles) rituximab:375mg/m2 d1 Dexamethasone:40mg d1-4 cyclophosphamide:750mg/m2,d1-28
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Drug: rituximab /Dexamethasone/cyclophosphamide
rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg |
Experimental: Velcade/Dex/CTX
Velcade/Dexamethasone/cyclophosphamide 6 cycles followed by velcade (at least 2 cycles) Velcade:1.3mg/m2 d1,d4,d8,d11 Dexamethasone:20mg d1-2,d4-5,d8-9,d11-12 cyclophosphamide:750mg/m2,d1-28
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Drug: Velcade/Dexamethasone/cyclophosphamide
Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg |
- Investigators try to compare the very good partial remission (VGPR) rate at the end of the research. [ Time Frame: 2 years ]
- Investigators try to compare the complete remission (CR) rates at the end of the research. [ Time Frame: 2 years ]
- Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research. [ Time Frame: 2 years ]
- Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research. [ Time Frame: 2 yeas ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recently diagnosed WM according to the second 2002 WM international working group
- Not previously treated, apart from not regularly received by Chlorambucil
- Aged from 18 to 75 years, both male and female
- Ability to give signed informed consent
- Negative pregnancy test at inclusion (if necessary)
- ECOG from 0 to 2
Exclusion Criteria:
- Known hypersensitivity to rituximab or velcade or cyclophosphamide
- Uncontrolled infection including bacteria, virus and fungus, including active HBV infection
- Organic dysfunction: Bilirubin > 1.5 x normal above, Renal failure requiring dialysis, glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) > 2.5 x normal above
- Positive HIV serology
- Serious psychiatric item in the history

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971982
Contact: Fu cheng cheng, PhD | 86-512-67781856 | evergirl@sina.com |
China, Jiangsu | |
First Affiliated Hospital, Soochow University | Recruiting |
Suzhou, Jiangsu, China, 215000 | |
Contact: Fu chengcheng, Phd 13962191404 evergirl@sina.com |
Principal Investigator: | Fu cheng cheng, Phd | First Affiliated Hospital,Soochow University |
Responsible Party: | The First Affiliated Hospital of Soochow University |
ClinicalTrials.gov Identifier: | NCT02971982 |
Other Study ID Numbers: |
myeloma-02 |
First Posted: | November 23, 2016 Key Record Dates |
Last Update Posted: | November 23, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Waldenstrom Macroglobulinemia Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Dexamethasone Dexamethasone acetate Cyclophosphamide Rituximab Bortezomib BB 1101 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |