CyBorD vs. PAD in the Treatment of Newly Diagnosed Multiple Myeloma

NCT02362165 | Unknown Phase 3

• 1 other identifier: SYSUCC-MM-308
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

Bortezomib-based triple-drug combination has greatly improved the response rate of multiple myeloma patients. Bortezomib,doxorubicin,and dexamethasone (PAD) is commonly used in clinical practice.Recent studies have found that cyclophosphamide, bortezomib,and dexamethasone (CyBorD)seems better than PAD in efficacy. However, there is no randomized phase 3 trial comparing these two regimens in the treatment of newly diagnosed multiple myeloma patients.In this study, the investigators will compare the efficacy and safety of these two regimens using once-weekly subcutaneous injection of bortezomib.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; cyclophosphamide; bortezomib; doxorubicin; peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy

  compare the Response assessment in both arms: the Very good partial response rate (according to the criteria IMWG) achieved with four courses of CyBorD with with that achieved with four courses of PAD

  date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)

Secondary Outcomes (2)

• complete response rate(according to the criteria IMWG) after four cycles of induction therapy

  date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)

• At least partial response rate (according to the criteria IMWG) after four cycles of induction therapy

  date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)

Study Arms (2)

CyBorD regimen

EXPERIMENTAL

this arm will receive cyclophosphamide (500mg/d,once-weekly),bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), and dexamethasone (40mg/d,once-weekly)(CyBorD) as induction therapy.

Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone

PAD regimen

ACTIVE COMPARATOR

this arm will receive bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), dexamethasone (40mg/d,once-weekly), and doxorubicin (9mg/㎡，d1-4)(PAD) as induction therapy.

Drug: Bortezomib; Drug: Dexamethasone; Drug: Doxorubicin

Interventions

Cyclophosphamide DRUG

500mg/d,once-weekly,per oral.

Also known as: endoxan

CyBorD regimen

Bortezomib DRUG

1.3mg/㎡,once-weekly,subcutaneous injection

Also known as: velcade

CyBorD regimen; PAD regimen

Dexamethasone DRUG

40mg/d,once-weekly,per oral

CyBorD regimen; PAD regimen

Doxorubicin DRUG

9mg/㎡,d1-4

Also known as: adriamycin

PAD regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosis of multiple myeloma
• Eastern Cooperative Oncology Group (ECOG) status 0-3,
• Estimated survival time \> 3 months
• Acceptable liver function (bilirubin\<2.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)\<2.5×ULN)
• No history of other malignancies
• No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation
• No other serious diseases which conflict with the treatment in the present trial
• No concurrent treatments that conflict with the treatments in the present trial
• Voluntary participation and signed the informed consent.

You may not qualify if:

• The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication;
• The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies
• The patients with neuropathy
• The patients with mentally ill / unable to obtain informed consent
• The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results
• The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects
• The patients with a history of allergy to test drug
• The patients not suitable to participate in the investigator judged by researchers.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Peripheral Nervous System Diseases

Interventions

Cyclophosphamide; Bortezomib; Dexamethasone; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Zhongjun Xia, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wang, Doctor

CONTACT

+862087342439; wangliang@sysucc.org.cn

Zhongjun Xia, Doctor

CONTACT

+862087342438; xiazhj@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: February 12, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CN (1)