AzTrials
AzTrials

Multiple MyelomaPhase 3NCT02362165

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

A Phase 3 study testing Cyclophosphamide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Cyclophosphamide, Bortezomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
1 siteChina
Study dates
Apr 2015to May 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Liang Wang, Doctor contact

+862087342439

wangliang@sysucc.org.cn

Zhongjun Xia, Doctor contact

+862087342438

xiazhj@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen university cancer center

    Guangzhou, Guangdong, 510060

    Zhongjun Xia, MD, 020-87342439, xiazhj@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 3 Trial Comparing Cyclophosphamide,Bortezomib,and Dexamethasone (CyBorD) and Bortezomib,Doxorubicin,and Dexamethasone (PAD) in the Treatment of Newly Diagnosed Multiple Myeloma

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.

Read the detailed description

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. Moreover, studies have found that subcutaneous injection of bortezomib can decrease the incidence rate of peripheral neuropathy induced by bortezomib, however, most center use twice-weekly administration of bortezomib. According to our experience, once-weekly subcutaneous injection of bortezomib can further decrease the incidence rate of peripheral neuropathy without compromising the efficacy. Thus, in this phase 3 trial, the investigators will compare the efficacy and safety of these two regimens using once-weekly subcutaneous injection of bortezomib.

Keywords
multiple myeloma, cyclophosphamide, bortezomib, doxorubicin, peripheral neuropathy
Medical subject headings
Multiple Myeloma, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02362165
Study groupRoleWhat they receive
CyBorD regimenExperimentalthis 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.
Receives: Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone
PAD regimenActive comparatorthis arm will receive bortezomib(1.3mg/㎡，once-weekly,subcutaneous injection), dexamethasone (40mg/d,once-weekly), and doxorubicin (9mg/㎡，d1-4)(PAD) as induction therapy.
Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)

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

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

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

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

    compare the Response assessment in both arms: the at least partial response rate (CR+VGPR+PR) (according to the criteria IMWG) achieved with four courses of CyBorD with with that achieved with four courses of PAD

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionApr 2018 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362165
Sponsor's protocol ID
SYSUCC-MM-308
Status last verified
Apr 2016
First submitted
8 Feb 2015
Last updated
20 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liang Wang, Doctor (+862087342439, wangliang@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

At least very good partial response rate (according to the criteria IMWG) after four cycles of induction therapy (time frame: date from randomization to 1 month after completion of 4 cycles of induction therapy (up to 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02362165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in