Multiple MyelomaPhase 3NCT02811978
Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma
A Phase 3 study testing Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 10 sites in China.
Trial summary
The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to intravenous velcade when administered in combination with low-dose dexamethasone in chinese refractory or relapsed multiple myeloma (r/rMM) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 10 sitesChina
- Study dates
- 27 Sep 2016to 10 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have received at least 1 and no more than 3 prior lines of therapy for multiple myeloma
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- The toxicities resulting from previous therapy must be resolved or stabilized to less than or equal (<=)Grade 1 prior to drug administration
- A woman of childbearing potential must have a negative highly sensitive serum (human chorionic gonadotropin [hCG]) or urine pregnancy tests at screening within 14 days prior to Cycle 1 Day 1
- Have documented evidence of progressive disease/disease progression based on investigator's determination of response by the International Myeloma Working Group (IMWG) criteria on or after their last regimen
Who cannot join
- Received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day (mg/day) for a maximum of 4 days) before treatment.
- Received autologous stem cell transplant (ASCT) within 12 weeks before the date of randomization, or the participant has previously received an allogenic stem cell transplant (regardless of timing)
- Plans to undergo a stem cell transplant prior to progression of disease on this study, that is, these participants should not be enrolled in order to reduce disease burden prior to transplant
- Is known to be infected with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C
- Had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Study site
Beijing
Study site
Chengdu
Study site
Chongqing
Study site
Fuzhou
Study site
Guangzhou
Study site
Nanjing
Study site
Shanghai
Study site
Suzhou
Study site
Tianjin
Study site
Wuhan
About this study
Official title: A Phase 3, Randomized, Open-label Study of Subcutaneous and Intravenous VELCADE in Combination With Dexamethasone in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to intravenous velcade when administered in combination with low-dose dexamethasone in chinese refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall response rate after 4 cycles of velcade and dexamethasone administration.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade, JNJ-26866138-AAA
Participants will receive 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of a 3 week cycle.
DexamethasoneDrug
Participants will receive Dexamethasone at a dose of 20 mg PO on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Intravenous Bortezomib plus Dexamethasone | Experimental | Participants will receive a 1.3 milligram per square meter per dose (mg/m^2) bortezomib intravenously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle). Receives: Drug: Bortezomib; Drug: Dexamethasone |
| Group 2 : Subcutaneous Bortezomib plus Dexamethasone | Experimental | Participants will receive a 1.3 milligram per square meter per dose (mg/m^2) bortezomib subcutaneously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle). Receives: Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate After 4 Cycles of Velcade Treatment
ORR defined as the proportion of participants who achieve either complete response [CR], very good partial response [VGPR], or partial response [PR], according to the International Myeloma Working Group (IMWG) criteria. Participants with CR, VGPR, or PR that is unconfirmed in Cycle 4 but confirmed in the next response assessment will be included as CR, VGPR or PR, respectively.
Measured: 12 weeks (after 4 cycles; each cycle is of 3 weeks)
Secondary outcomes (12)
Complete Response (CR) and Very Good Partial Response (VGPR) after 4 cycles
CR and VGPR defined as the proportion of participants who achieve either complete response [CR] or very good partial response [VGPR], according to the IMWG criteria, after 4 cycles of Velcade treatment. Participants with CR or VGPR that is unconfirmed in Cycle 4 but further confirmed in the next response assessment will be included.
Measured: 12 weeks (after 4 cycles; each cycle is of 3 weeks)
Overall Response Rate (ORR) after 8 cycles
ORR is defined as the proportion of participants who achieve either CR, VGPR, or PR according to the IMWG criteria, after 8 cycles of Vd treatment. Participants with CR, VGPR or PR that is unconfirmed in Cycle 8 but further confirmed in the next response assessment will be included.
Measured: 24 weeks (after 8 cycle; each cycle is of 3 weeks)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented progressive disease/disease progression (PD), or death due to any cause, whichever occurs earlier. Participants who have not progressed and are alive on the cut-off date for analysis will be censored at the date of the last clinical assessment of response.
Measured: Maximum up to 4 years 7 months
One-year survival rate
One-year survival rate is defined as survival rate at 1 year after randomization. If a participant is alive or the vital status is unknown, then data will be censored at the date that the participant is last known to be alive.
Measured: 1 year after last patient randomization
Time to response
Time to response is defined as the time from the date of randomization to the date of the first documentation of a confirmed CR, VGPR, or PR. Participants without response (CR/VGPR/PR) will be censored either at PD or at the last clinical assessment of response.
Measured: Maximum up to 4 years 7 months
Time to progression (TTP)
Time to progression is defined as the time from the date of randomization to the date of first documentation of PD. Participants who have not progressed will be censored at the date of the last clinical assessment of response.
Measured: Maximum up to 4 years 7 months
Duration of response (DOR)
Duration of response is defined as the time from the date of first documentation of a confirmed CR, VGPR, or PR (overall cycles) to the date of first documented PD. Responders without PD will be censored at the date of the last clinical assessment of response.
Measured: Maximum up to 4 years 7 months
Time to best response
Time to best response is defined as the time from the date of randomization to the date of the first evaluation of the overall best response (CR/VGPR/PR) to treatment. Participants without response (CR/VGPR/PR) will be censored either at PD or at the last clinical assessment of response.
Measured: Maximum up to 4 years 7 months
Maximum Observed Plasma Concentration (Cmax)
Drug concentration vs. time profile following the 4th dose in Cycle 1 and derived Pharmacokinetic (PK) parameter Cmax will be assessed. Cmax is the observed maximum plasma concentration, taken directly from the plasma concentration-time profile.
Measured: Cycle 1 of Day 1, Day 11 to Day 14
Area Under the Plasma ConcentrationTime Curve From Time 0 to Last Observed Quantifiable Concentration AUC [0-last]
Drug concentration vs. time profile following the 4th dose in Cycle 1 and derived Pharmacokinetic (PK) parameter AUC [0-last] will be assessed. AUC [0-last] is the area under the plasma-concentration versus time curve from time 0 to the time of last quantifiable time point, calculated by linear trapezoidal summation.
Measured: Cycle 1 of Day 1, Day 11 to Day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Drug concentration vs. time profile following the 4th dose in Cycle 1 and derived Pharmacokinetic (PK) parameter Tmax will be assessed. Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.
Measured: Cycle 1 of Day 1, Day 11 to Day 14
Number of Participants with Treatment-Related Adverse Events and Serious Treatment-Related Adverse Events
Number of Participants with adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0.3 and also vital signs, clinical laboratory tests, local injection site tolerability, and electrocardiograms (ECGs) will be assessed.
Measured: Maximum up to 4 years 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start27 Sep 2016
- Primary completion7 May 2018
- Study completion10 Nov 2018
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 Janssen Research & Development, LLCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811978
- Sponsor's protocol ID
- CR108175
- Other IDs
- 26866138MMY3037
- Status last verified
- Oct 2019
- First submitted
- 26 May 2016
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label Study of Subcutaneous and Intravenous VELCADE in Combination With Dexamethasone in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02811978
- Acronym / sponsor ID
- CR108175
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 23 Jun 2016 (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 phase 3 study is to determine if subcutaneous velcade is non-inferior to intravenous velcade when administered in combination with low-dose dexamethasone in chinese refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall response rate after 4 cycles of velcade and dexamethasone administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Intravenous Bortezomib plus Dexamethasone | Experimental | Drug: Bortezomib, Drug: DexamethasoneParticipants will receive a 1.3 milligram per square meter per dose (mg/m^2) bortezomib intravenously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle). |
| Group 2 : Subcutaneous Bortezomib plus Dexamethasone | Experimental | Drug: Bortezomib, Drug: DexamethasoneParticipants will receive a 1.3 milligram per square meter per dose (mg/m^2) bortezomib subcutaneously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have received at least 1 and no more than 3 prior lines of therapy for multiple myeloma
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- The toxicities resulting from previous therapy must be resolved or stabilized to less than or equal (<=)Grade 1 prior to drug administration
- A woman of childbearing potential must have a negative highly sensitive serum (human chorionic gonadotropin [hCG]) or urine pregnancy tests at screening within 14 days prior to Cycle 1 Day 1
- Have documented evidence of progressive disease/disease progression based on investigator's determination of response by the International Myeloma Working Group (IMWG) criteria on or after their last regimen
Key exclusion criteria (5 listed)
- Received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day (mg/day) for a maximum of 4 days) before treatment.
- Received autologous stem cell transplant (ASCT) within 12 weeks before the date of randomization, or the participant has previously received an allogenic stem cell transplant (regardless of timing)
- Plans to undergo a stem cell transplant prior to progression of disease on this study, that is, these participants should not be enrolled in order to reduce disease burden prior to transplant
- Is known to be infected with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C
- Had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities
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 |
|---|---|---|
| BortezomibAlso: Velcade, JNJ-26866138-AAAParticipants will receive 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of a 3 week cycle. | Drug | Group 1 : Intravenous Bortezomib plus Dexamethasone, Group 2 : Subcutaneous Bortezomib plus Dexamethasone |
| DexamethasoneParticipants will receive Dexamethasone at a dose of 20 mg PO on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle). | Drug | Group 1 : Intravenous Bortezomib plus Dexamethasone, Group 2 : Subcutaneous Bortezomib plus Dexamethasone |
Primary outcome
Overall Response Rate After 4 Cycles of Velcade Treatment
Time frame: 12 weeks (after 4 cycles; each cycle is of 3 weeks)
ORR defined as the proportion of participants who achieve either complete response [CR], very good partial response [VGPR], or partial response [PR], according to the International Myeloma Working Group (IMWG) criteria. Participants with CR, VGPR, or PR that is unconfirmed in Cycle 4 but confirmed in the next response assessment will be included as CR, VGPR or PR, respectively.
12 secondary outcomes
Complete Response (CR) and Very Good Partial Response (VGPR) after 4 cycles
Time frame: 12 weeks (after 4 cycles; each cycle is of 3 weeks)
Overall Response Rate (ORR) after 8 cycles
Time frame: 24 weeks (after 8 cycle; each cycle is of 3 weeks)
Progression-Free Survival (PFS)
Time frame: Maximum up to 4 years 7 months
One-year survival rate
Time frame: 1 year after last patient randomization
Time to response
Time frame: Maximum up to 4 years 7 months
Time to progression (TTP)
Time frame: Maximum up to 4 years 7 months
Duration of response (DOR)
Time frame: Maximum up to 4 years 7 months
Time to best response
Time frame: Maximum up to 4 years 7 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 of Day 1, Day 11 to Day 14
Area Under the Plasma ConcentrationTime Curve From Time 0 to Last Observed Quantifiable Concentration AUC [0-last]
Time frame: Cycle 1 of Day 1, Day 11 to Day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Cycle 1 of Day 1, Day 11 to Day 14
Number of Participants with Treatment-Related Adverse Events and Serious Treatment-Related Adverse Events
Time frame: Maximum up to 4 years 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- A Phase 3, Randomized, Open-label Study of Subcutaneous and Intravenous VELCADE® in Combination with Dexamethasone in Chinese Subjects with Relapsed or Refractory Multiple MyelomaLink provided by the sponsor.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 10 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Response Rate After 4 Cycles of Velcade Treatment (time frame: 12 weeks (after 4 cycles; each cycle is of 3 weeks)). 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 8 Nov 2019.