Plasma Cell LeukemiaPhase 2BortezomibNCT01328236
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
A Phase 2 study testing Bortezomib, Liposome doxorubicin and Dexamethasone in people with Plasma Cell Leukemia and Multiple Myeloma, run by Clinical Service, China at 1 site in China.
Trial summary
Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM). The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasma Cell Leukemia, Multiple Myeloma
- What is being tested?
- Bortezomib, Liposome doxorubicin and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Sep 2015
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients confirmed relapsed or refractory PCL who previously untreated or never received treatment with Bortezomib
- KPS ≥ 60
- Adequate liver and renal function within 2 weeks of Screening:
- Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)
- Cardiac function > Ⅲ grade and ejection fraction > 45%
- Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care
Who cannot join
- has taken Bortezomib
- KPS ≤ 60 scores
- mental illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Clinical Service Center
Beijing, Beijing Municipality
zhao wang, M.D, 861063138303 ext. 861063138303, zhaowww263@yahoo.com
About this study
Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).
The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).
Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).
Read the detailed description
Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores
- Conditions
- Plasma Cell Leukemia, Multiple Myeloma
- Being tested
- Bortezomib, Liposome doxorubicin, Dexamethasone
- Keywords
- Bortezomib, PCL
- Medical subject headings
- Leukemia, Plasma Cell, 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
INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
Liposome doxorubicinDrug
Also called Caelyx
INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
DexamethasoneDrug
Also called Acidocont, Deronil, Dexacortal, dexametona, Flumeprednisolon
INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| V-DD single arm | Experimental | INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment.
Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. Receives: Drug: Bortezomib; Drug: Liposome doxorubicin; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria
Measured: Day 1 of every treatment cycle
Secondary outcomes (6)
the rate of response
The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
Measured: Day 1 of every treatment cycle
partial remission rate
The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.
Measured: Day 1 of every treatment cycle
duration of response
Measured: up to 6 months
overall survival
Measured: up to two and a half year
Adverse Events
Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.
Measured: up to two and a half years
FACT/GOC-Ntx
Measured: Day 1 of every treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell LeukemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Service, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harbin Hematology and Oncology Institute, Shanghai Changzheng Hospital, Chinese PLA General Hospital, 307 Hospital of PLA, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Beijing Chao Yang Hospital, Henan Provincial People's Hospital, Peking University Third Hospital
- Responsible party
- Principal investigator, wangzhao, Clinical Service, China
- Investigators
- zhao wang, Master, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328236
- Sponsor's protocol ID
- 26866138CAN2026
- Acronym
- Bortezomib
- Status last verified
- Sep 2011
- First submitted
- 29 Mar 2011
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
- ClinicalTrials.gov ID
- NCT01328236
- Acronym / sponsor ID
- Bortezomib / 26866138CAN2026
- Conditions
- Plasma Cell Leukemia, Multiple Myeloma
- Keywords
- Bortezomib, PCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clinical Service, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Harbin Hematology and Oncology Institute, Shanghai Changzheng Hospital, Chinese PLA General Hospital, 307 Hospital of PLA, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Beijing Chao Yang Hospital, Henan Provincial People's Hospital, Peking University Third Hospital
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 4 Apr 2011 (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.
Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).
The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).
Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).
Detailed description
Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-DD single arm | Experimental | Drug: Bortezomib, Drug: Liposome doxorubicin, Drug: DexamethasoneINDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment. Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients confirmed relapsed or refractory PCL who previously untreated or never received treatment with Bortezomib
- KPS ≥ 60
- Adequate liver and renal function within 2 weeks of Screening:
- Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of normal (ULN)
Key exclusion criteria (3 listed)
- has taken Bortezomib
- KPS ≤ 60 scores
- mental illness
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: VelcadeINDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. | Drug | V-DD single arm |
| Liposome doxorubicinAlso: CaelyxINDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. | Drug | V-DD single arm |
| DexamethasoneAlso: Acidocont, Deronil, Dexacortal, dexametona, FlumeprednisolonINDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops. MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops. | Drug | V-DD single arm |
Primary outcome
overall response rate
Time frame: Day 1 of every treatment cycle
The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria
6 secondary outcomes
the rate of response
Time frame: Day 1 of every treatment cycle
partial remission rate
Time frame: Day 1 of every treatment cycle
duration of response
Time frame: up to 6 months
overall survival
Time frame: up to two and a half year
Adverse Events
Time frame: up to two and a half years
FACT/GOC-Ntx
Time frame: Day 1 of every treatment cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
Related trials for Plasma Cell Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
RecruitingObservational study
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Graft-versus-leukemia, Graft vs Host Disease
Active, not recruitingPhase 2
A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia
Plasma Cell Leukemia
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.
zhao wang, Master principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib, Liposome doxorubicin and Dexamethasone in people with Plasma Cell Leukemia and Multiple Myeloma, run by Clinical Service, China 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 3 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 22 Sep 2011. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: Day 1 of every treatment 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 22 Sep 2011.