Multiple MyelomaPhase 4NCT02577783
PDD vs PAD to Treat Initially Diagnosed MM
A Phase 4 study testing PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone and PAD regimen: bortizomib, dexamethasone and doxorubicin in people with Multiple Myeloma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone and PAD regimen: bortizomib, dexamethasone and doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2021
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed and untreated multiple myeloma patients
- Patients with age between 18 and 70 years
- With a evaluable disease
- ECOG score ≤2
- NE≥1.0×10E9 /L, Plt≥50×10E9 /L, Hb≥70 g/L
- AST, ALT, ALP≤3×ULN, serum BIL≤ULN
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- LVEF≥ 50%
- Not in pregnancy
- Written informed consent are acquired
Who cannot join
- Severe heart failure (NYHA grade II or higher)
- Active and uncontrolled severe infection
- HIV positive
- Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride iposome or doxorubicin
- Grade 2 or higher peripheral neuropathy before treatment
- Have suffered any other malignancy in past 5 years
- Females in lactation
- Other situations that investigators consider as contra-indication for this study
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study
The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone, PAD regimen: bortizomib, dexamethasone and doxorubicin
- Keywords
- Doxorubicin Hydrochloride
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasoneDrug
doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong)
PAD regimen: bortizomib, dexamethasone and doxorubicinDrug
doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong)
| Study group | Role | What they receive |
|---|---|---|
| PDD arm | Experimental | patients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone ) Receives: Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone |
| PAD arm | Active comparator | patients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone ) Receives: Drug: PAD regimen: bortizomib, dexamethasone and doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
sCR + CR + VGPR
Measured: 4 cycles (each cycle is 28 days) of chemotherapy
Secondary outcomes (3)
Overall remission rate
sCR + CR
Measured: 4 cycles (each cycle is 28 days) of chemotherapy
Progression-free survival
Measured: 3 year
Adverse Event
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577783
- Sponsor's protocol ID
- SZ5202
- Status last verified
- Feb 2020
- First submitted
- 7 Oct 2015
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02577783
- Acronym / sponsor ID
- SZ5202
- Conditions
- Multiple Myeloma
- Keywords
- Doxorubicin Hydrochloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDD arm | Experimental | Drug: PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasonepatients involved in PDD arm will accept chemotherapy of PDD regimen (doxorubicin hydrochloride liposome plus bortizomib and dexamethasone ) |
| PAD arm | Active comparator | Drug: PAD regimen: bortizomib, dexamethasone and doxorubicinpatients involved in PAD arm will accept chemotherapy of PAD regimen (doxorubicinplus bortizomib and dexamethasone ) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed and untreated multiple myeloma patients
- Patients with age between 18 and 70 years
- With a evaluable disease
- ECOG score ≤2
- NE≥1.0×10E9 /L, Plt≥50×10E9 /L, Hb≥70 g/L
Key exclusion criteria (8 listed)
- Severe heart failure (NYHA grade II or higher)
- Active and uncontrolled severe infection
- HIV positive
- Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride iposome or doxorubicin
- Grade 2 or higher peripheral neuropathy before treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasonedoxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong) | Drug | PDD arm |
| PAD regimen: bortizomib, dexamethasone and doxorubicindoxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong) | Drug | PAD arm |
Primary outcome
Response rate
Time frame: 4 cycles (each cycle is 28 days) of chemotherapy
sCR + CR + VGPR
3 secondary outcomes
Overall remission rate
Time frame: 4 cycles (each cycle is 28 days) of chemotherapy
Progression-free survival
Time frame: 3 year
Adverse Event
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone and PAD regimen: bortizomib, dexamethasone and doxorubicin in people with Multiple Myeloma, run by The First Affiliated Hospital of Soochow 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 5 Feb 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 4 cycles (each cycle is 28 days) of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.