Multiple MyelomaPhase 2NCT00706953
A Study of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed Multiple Myeloma Previously Treated With Bortezomib
A Phase 2 study testing bortezomib; pegylated liposomal doxorubicin in people with Multiple Myeloma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of using pegylated liposomal doxorubicin and bortezomib in the treatment of patients with relapsed multiple myeloma who had been previously treated with bortezomib. 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; pegylated liposomal doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jun 2010
- Phase
- Phase 2
- 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
- Confirmed diagnosis of Multiple Myeloma
- Received prior courses of bortezomib (VELCADE)-based therapy
- Greater than or equal to 50% reduction in M-Protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of VELCADE-based therapy
- 60 days or more since the patient's last VELCADE dose
- Life expectancy > 3 months
- Progressive disease defined by new or worsening lytic bone lesions or plasmacytoma or hypercalcemia or a >25% increase in M-protein
Who cannot join
- No patients with progressive disease while receiving an anthracycline-based regimen
- No patients with >2 prior regimens for the treatment of multiple myeloma
- No major surgery within 2 weeks before screening
- No patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent
- No patients known to be human immunodeficiency virus (HIV) positive
- No patients with poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness
- No patients with an active systemic infection requiring treatment
About this study
Official title: A Phase II Single Arm Study of VELCADE and DOXIL (PLD) in Patients With Relapsed Multiple Myeloma Previously Treated With VELCADE
The purpose of this study is to evaluate the safety and effectiveness of using pegylated liposomal doxorubicin and bortezomib in the treatment of patients with relapsed multiple myeloma who had been previously treated with bortezomib. Multiple myeloma is a cancer that begins in plasma cells, a type of white blood cell. These cells are part of the immune system, which helps protect the body from germs and other harmful substances. In time, myeloma cells collect in the bone marrow and in the solid parts of bone. Multiple myeloma treatment may include stem cell transplantation, however, not all patients with multiple myeloma are candidates for stem cell transplantation and many patients who receive transplants relapse. As a result, additional first and later-line therapeutic options are needed for patients who are not candidates for transplantation, or whose disease relapses after transplantation or other therapies. Pegylated liposomal doxorubicin in combination with bortezomib is approved for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. The combined use of pegylated liposomal doxorubicin and bortezomib in this study is designed to evaluate the overall response rate and safety in patients with multiple myeloma who have been previously treated with bortezomib.
Read the detailed description
The primary purpose of this study is to evaluate the overall response rate to DOXIL/VELCADE treatment in patients with relapsed multiple myeloma previously treated with VELCADE. Overall response rate is defined as the proportion of patients achieving either a complete response (CR) or partial response (PR) to treatment according to the European Group for Blood and Marrow Transplantation (EBMT) criteria. This is a single arm (all patients will receive the same drug combination and dose), multi-center (many study sites), open label (the patient and the physician know the drug treatment being received) of approximately 60 patients with multiple myeloma whose disease has progressed after initial response to VELCADE-based therapy. During each 21-day treatment cycle, patients will receive VELCADE by intravenous bolus on 4 designated days, and DOXIL by intravenous infusion on one designated day. Treatment will continue until disease progression, or the occurrence of unacceptable treatment-related toxicity or up to a total of 8 cycles of therapy. Drug doses may be delayed or dropped as needed to allow for platelet transfusions or other treatment requirements. Patients responding to treatment at study end may be evaluated for continued treatment for as long as treatment can be tolerated and they continue to respond. After discontinuation of all study drugs, patients who have not had disease progression will be followed for 6 months after receiving the last dose of study drug. The primary endpoint is overall response rate as defined by the proportion of patients achieving either a complete response or a partial response. Response will be assessed at each cycle. Safety will be monitored throughout the study by physical examination, clinical laboratory testing, and the incidence and severity of reported adverse events. Overall safety will be summarized at study-end.
During each 21-day treatment cycle, patients will receive bortezomib 1.3 mg/m2 by intravenous bolus on Days 1, 4, 8 and 11 and pegylated liposomal doxorubicin 30 mg/m2 by intravenous infusion on Day 4.
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib; pegylated liposomal doxorubicin
- Keywords
- pegylated liposomal doxorubicin, VELCADE, DOXIL, relapsed, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomib; pegylated liposomal doxorubicinDrug
1.3 mg/m2 IV bolus on Days 1,4,8,11 of each 21-day cycle; 30 mg/m2 IV infusion on Day 4 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| 001 | Active comparator | Not described Receives: Drug: bortezomib; pegylated liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the overall response rate defined as the partial or complete response to treatment according to EBMT criteria. Overall response will be assessed at each treatment cycle up to 8 cycles.
Measured: Assessed at each 21-day treatment cycle up to 8 cycles and over 6 months following discontinuation of all study drugs.
Secondary outcomes (1)
Secondary endpoints include time to disease progression (treatment start to disease progression or death due to progression); best response assessed by the investigator; duration of response; and overall survival (treatment start to death by any cause).
Measured: Day 1, Cycle 1 throughout treatment cycles and follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706953
- Sponsor's protocol ID
- CR015091
- Other IDs
- DOXILMMY2009
- Status last verified
- Apr 2015
- First submitted
- 26 Jun 2008
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single Arm Study of VELCADE and DOXIL (PLD) in Patients With Relapsed Multiple Myeloma Previously Treated With VELCADE
- ClinicalTrials.gov ID
- NCT00706953
- Acronym / sponsor ID
- CR015091
- Conditions
- Multiple Myeloma
- Keywords
- pegylated liposomal doxorubicin, VELCADE, DOXIL, relapsed, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Study start
- Jul 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 30 Jun 2008 (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 evaluate the safety and effectiveness of using pegylated liposomal doxorubicin and bortezomib in the treatment of patients with relapsed multiple myeloma who had been previously treated with bortezomib. Multiple myeloma is a cancer that begins in plasma cells, a type of white blood cell. These cells are part of the immune system, which helps protect the body from germs and other harmful substances. In time, myeloma cells collect in the bone marrow and in the solid parts of bone. Multiple myeloma treatment may include stem cell transplantation, however, not all patients with multiple myeloma are candidates for stem cell transplantation and many patients who receive transplants relapse. As a result, additional first and later-line therapeutic options are needed for patients who are not candidates for transplantation, or whose disease relapses after transplantation or other therapies. Pegylated liposomal doxorubicin in combination with bortezomib is approved for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. The combined use of pegylated liposomal doxorubicin and bortezomib in this study is designed to evaluate the overall response rate and safety in patients with multiple myeloma who have been previously treated with bortezomib.
Detailed description
The primary purpose of this study is to evaluate the overall response rate to DOXIL/VELCADE treatment in patients with relapsed multiple myeloma previously treated with VELCADE. Overall response rate is defined as the proportion of patients achieving either a complete response (CR) or partial response (PR) to treatment according to the European Group for Blood and Marrow Transplantation (EBMT) criteria. This is a single arm (all patients will receive the same drug combination and dose), multi-center (many study sites), open label (the patient and the physician know the drug treatment being received) of approximately 60 patients with multiple myeloma whose disease has progressed after initial response to VELCADE-based therapy. During each 21-day treatment cycle, patients will receive VELCADE by intravenous bolus on 4 designated days, and DOXIL by intravenous infusion on one designated day. Treatment will continue until disease progression, or the occurrence of unacceptable treatment-related toxicity or up to a total of 8 cycles of therapy. Drug doses may be delayed or dropped as needed to allow for platelet transfusions or other treatment requirements. Patients responding to treatment at study end may be evaluated for continued treatment for as long as treatment can be tolerated and they continue to respond. After discontinuation of all study drugs, patients who have not had disease progression will be followed for 6 months after receiving the last dose of study drug. The primary endpoint is overall response rate as defined by the proportion of patients achieving either a complete response or a partial response. Response will be assessed at each cycle. Safety will be monitored throughout the study by physical examination, clinical laboratory testing, and the incidence and severity of reported adverse events. Overall safety will be summarized at study-end.
During each 21-day treatment cycle, patients will receive bortezomib 1.3 mg/m2 by intravenous bolus on Days 1, 4, 8 and 11 and pegylated liposomal doxorubicin 30 mg/m2 by intravenous infusion on Day 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Active comparator | Drug: bortezomib; pegylated liposomal doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of Multiple Myeloma
- Received prior courses of bortezomib (VELCADE)-based therapy
- Greater than or equal to 50% reduction in M-Protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of VELCADE-based therapy
- 60 days or more since the patient's last VELCADE dose
- Life expectancy > 3 months
Key exclusion criteria (7 listed)
- No patients with progressive disease while receiving an anthracycline-based regimen
- No patients with >2 prior regimens for the treatment of multiple myeloma
- No major surgery within 2 weeks before screening
- No patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent
- No patients known to be human immunodeficiency virus (HIV) positive
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 |
|---|---|---|
| bortezomib; pegylated liposomal doxorubicin1.3 mg/m2 IV bolus on Days 1,4,8,11 of each 21-day cycle; 30 mg/m2 IV infusion on Day 4 of each 21 day cycle | Drug | 001 |
Primary outcome
The primary endpoint is the overall response rate defined as the partial or complete response to treatment according to EBMT criteria. Overall response will be assessed at each treatment cycle up to 8 cycles.
Time frame: Assessed at each 21-day treatment cycle up to 8 cycles and over 6 months following discontinuation of all study drugs.
1 secondary outcome
Secondary endpoints include time to disease progression (treatment start to disease progression or death due to progression); best response assessed by the investigator; duration of response; and overall survival (treatment start to death by any cause).
Time frame: Day 1, Cycle 1 throughout treatment cycles and follow-up.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib; pegylated liposomal doxorubicin in people with Multiple Myeloma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint is the overall response rate defined as the partial or complete response to treatment according to EBMT criteria. Overall response will be assessed at each treatment cycle up to 8 cycles. (time frame: Assessed at each 21-day treatment cycle up to 8 cycles and over 6 months following discontinuation of all study drugs.). 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 Apr 2015.