Multiple MyelomaPhase 4NCT01868828
A Study of PAD Versus Velcade, Cyclophosphamide and Dexamethasone (VCD) Treatment in Subjects With Multiple Myeloma
A Phase 4 study testing PAD, VCD and ASCT in people with Multiple Myeloma, run by Peking University People's Hospital at 1 site in China.
Trial summary
A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50 previously untreated subjects with multiple myeloma will be enrolled. The study will consist of 6 phases, screening, treatment and follow-up. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- PAD, VCD and ASCT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 2017
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men or women aged <65 years.
- Previously untreated subjects with multiple myeloma.
- No clinically significant cardiac amyloidosis (Echocardiography septal≤10mm, brain natriuretic peptide (BNP) < 500).
- Pulmonary infection (if any) must be controlled effectively.
- Chronic viral hepatitis (if any) must be controlled effectively.(Subjects with HBs Ag positive need to monitor hepatitis B virus-DNA (HBV-DNA )quantitative test regularly）；
- Liver function (aminotransferase, bilirubin）?2 x the upper limit of normal (ULN).
- Expected lifetime More than 3 months.
- Be able to read and sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Who cannot join
- Patients with relapsed multiple myeloma.
- Need to change the program according to the researchers' evaluated patients with disease progression during treatment.
- Had uncontrolled or severe cardiovascular disease. Had a myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
- Has a history of allergic reaction to compounds containing boron or mannitol.
- Severe neuropathy may affect the treatment, according to the researchers to determine.
- According to the program or the investigator's judgment, the patient is suffering from a serious physical illness or mental illness may interfere with participation in this clinical study.
- Concurrent treatment with another investigational agent.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
Jin Lu, PhD contact
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital, Institute of Hematology, Peking University
Beijing, Beijing Municipality, 100044
Jin Lu, PhD, onco_velcade123@163.com
About this study
Official title: A Multicenter, Double Arms, Prospective Phase 4 Study to Evaluating the Efficacy and Safety of Combination Therapy of PAD Versus VCD Treatment in Previously Untreated Subjects With Multiple Myeloma.
A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50 previously untreated subjects with multiple myeloma will be enrolled. The study will consist of 6 phases, screening, treatment and follow-up.
Read the detailed description
Screening
At the screening visit, informed consent will be obtained from all subjects who are deemed potentially eligible for enrollment in the study, according to the protocol-specified inclusion and exclusion criteria.
Treatment
Eligible patients are randomly assigned to receive either treatment PAD or VCD. All eligible subjects will be evaluated after 4 cycles treatment. According to the assessment of researchers and the willingness of patients to decide whether to autologous stem-cell transplantation (ASCT). Suitable for transplant patients will accept hematopoietic stem cell transplantation. Not suitable for transplant patients will continue accept treatment for 8 cycles. The patients who accept more than 4 cycles treatment will receive efficacy evaluation.
Follow-up
All patients will receive 12 months of follow-up after the treatment period. Follow-up at 4, 6, 8 and 12 month after the treatment period respectively. Subjects who have disease progression or accept other resistance myeloma therapy during the 12 months of follow-up phase will stop assessed about the study and start followed up only for survival status every 6 months through telephone interviews or to research center follow-up. All patients will accept the follow-up for survival until last case patient who complete follow-up.
Safety will be evaluated throughout the study by assessment of adverse events (AEs), physical examination, vital signs and clinical laboratory findings.
- Conditions
- Multiple Myeloma
- Being tested
- PAD, VCD, ASCT
- Keywords
- Multiple Myeloma, Combination Therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PADDrug
Also called Induction Therapy
Induction Therapy of PAD for 4 cycles.
VCDDrug
Also called Induction Therapy
Induction Therapy of VCD for 4 cycles.
ASCTOther
Not suitable for transplant patients will continue accept treatment for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| PAD Followed by ASCT | Experimental | Drug: Bortezomib(1.3mg/m2, iv, on day 1, 4, 8, 11)
Drug: Epidoxorubicin(15 mg/m2, iv, on days 1-4)
Drug: Dexamethasone(40mg, orally, on days 1-4)
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
Not suitable for transplant patients will continue accept treatment for 8 cycles. Receives: Drug: PAD; Other: ASCT |
| VCD Followed by ASCT | Experimental | Drug: Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11)
Drug: Cyclophosphamide (200mg/m2, orally, on days 1-5)
Drug: Dexamethasone(40mg, orally, on days 1-4)
After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
Not suitable for transplant patients will continue accept treatment for 8 cycles. Receives: Drug: VCD; Other: ASCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Measured: Up to cycle 4 (with 28 days per cycle).
Secondary outcomes (5)
Safety
Safety evaluations will be based on scheduled clinical laboratory tests, electrocardiogram or cardiac ultrasonography (when appropriate), vital signs, physical examination and number of adverse events.
Measured: At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Overall Response Rate
Overall response rate included Complete Response (CR), Very good partial response (VGPR) and PR, before the new treatment, two consecutive evaluations are in line with defined criteria in order to confirm the efficacy evaluation.
Measured: At baseline, on day 28 of each cycle for 4 cycles.
Time To Response
Measured: At baseline, on day 28 of each cycle for 4 cycles.
1-year Survival Rate
Measured: At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Overall Survival
Measured: At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2017 (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 Peking University People's HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, Peking University People's Hospital
- Investigators
- Jin Lu, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868828
- Sponsor's protocol ID
- PAD VS VCD Clinical Protocol
- Status last verified
- Jun 2013
- First submitted
- 22 May 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double Arms, Prospective Phase 4 Study to Evaluating the Efficacy and Safety of Combination Therapy of PAD Versus VCD Treatment in Previously Untreated Subjects With Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT01868828
- Acronym / sponsor ID
- PAD VS VCD Clinical Protocol
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Combination Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 5 Jun 2013 (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.
A multicenter, double arms, prospective randomized controlled phase 4 study. Approximately 50 previously untreated subjects with multiple myeloma will be enrolled. The study will consist of 6 phases, screening, treatment and follow-up.
Detailed description
Screening
At the screening visit, informed consent will be obtained from all subjects who are deemed potentially eligible for enrollment in the study, according to the protocol-specified inclusion and exclusion criteria.
Treatment
Eligible patients are randomly assigned to receive either treatment PAD or VCD. All eligible subjects will be evaluated after 4 cycles treatment. According to the assessment of researchers and the willingness of patients to decide whether to autologous stem-cell transplantation (ASCT). Suitable for transplant patients will accept hematopoietic stem cell transplantation. Not suitable for transplant patients will continue accept treatment for 8 cycles. The patients who accept more than 4 cycles treatment will receive efficacy evaluation.
Follow-up
All patients will receive 12 months of follow-up after the treatment period. Follow-up at 4, 6, 8 and 12 month after the treatment period respectively. Subjects who have disease progression or accept other resistance myeloma therapy during the 12 months of follow-up phase will stop assessed about the study and start followed up only for survival status every 6 months through telephone interviews or to research center follow-up. All patients will accept the follow-up for survival until last case patient who complete follow-up.
Safety will be evaluated throughout the study by assessment of adverse events (AEs), physical examination, vital signs and clinical laboratory findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAD Followed by ASCT | Experimental | Drug: PAD, Other: ASCTDrug: Bortezomib(1.3mg/m2, iv, on day 1, 4, 8, 11) Drug: Epidoxorubicin(15 mg/m2, iv, on days 1-4) Drug: Dexamethasone(40mg, orally, on days 1-4) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. Not suitable for transplant patients will continue accept treatment for 8 cycles. |
| VCD Followed by ASCT | Experimental | Drug: VCD, Other: ASCTDrug: Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11) Drug: Cyclophosphamide (200mg/m2, orally, on days 1-5) Drug: Dexamethasone(40mg, orally, on days 1-4) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. Not suitable for transplant patients will continue accept treatment for 8 cycles. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women aged <65 years.
- Previously untreated subjects with multiple myeloma.
- No clinically significant cardiac amyloidosis (Echocardiography septal≤10mm, brain natriuretic peptide (BNP) < 500).
- Pulmonary infection (if any) must be controlled effectively.
- Chronic viral hepatitis (if any) must be controlled effectively.(Subjects with HBs Ag positive need to monitor hepatitis B virus-DNA (HBV-DNA )quantitative test regularly）；
Key exclusion criteria (8 listed)
- Patients with relapsed multiple myeloma.
- Need to change the program according to the researchers' evaluated patients with disease progression during treatment.
- Had uncontrolled or severe cardiovascular disease. Had a myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
- Has a history of allergic reaction to compounds containing boron or mannitol.
- Severe neuropathy may affect the treatment, according to the researchers to determine.
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 |
|---|---|---|
| PADAlso: Induction TherapyInduction Therapy of PAD for 4 cycles. | Drug | PAD Followed by ASCT |
| VCDAlso: Induction TherapyInduction Therapy of VCD for 4 cycles. | Drug | VCD Followed by ASCT |
| ASCTNot suitable for transplant patients will continue accept treatment for 8 cycles. | Other | PAD Followed by ASCT, VCD Followed by ASCT |
Primary outcome
Complete Response Rate
Time frame: Up to cycle 4 (with 28 days per cycle).
5 secondary outcomes
Safety
Time frame: At baseline, on day 1 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Overall Response Rate
Time frame: At baseline, on day 28 of each cycle for 4 cycles.
Time To Response
Time frame: At baseline, on day 28 of each cycle for 4 cycles.
1-year Survival Rate
Time frame: At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Overall Survival
Time frame: At baseline, on day 28 of each cycle, and after 4, 6, 12 and 18 months of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
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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.
Jin Lu, PhD contact
Jin Lu, PhD principal investigator
Peking University People's Hospital
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 PAD, VCD and ASCT in people with Multiple Myeloma, run by Peking University People's Hospital 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 8 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 6 Jun 2013. 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?
Contact Jin Lu, PhD (onco_velcade123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: Up to cycle 4 (with 28 days per cycle).). 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 6 Jun 2013.