Multiple MyelomaPhase 4NCT02559154
Modified Bortezomib-based Combination Therapy for Multiple Myeloma
A Phase 4 study testing Bortezomib, Dexamethasone and Doxorubicin in people with Multiple Myeloma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib, Dexamethasone and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple myeloma based on standard diagnosis criteria:
- plasmacytomas on tissue biopsy
- bone marrow plasmacytosis
- monoclonal immunoglobulin spike on serum electrophoresis
- lytic bone lesions.
- Must have relapsed or relapsed/refractory disease
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- 18 years of age or older
- All baseline studies must be performed within 21 days of enrollment.
- ECOG performance status of 0 to 2
Who cannot join
- Renal insufficiency (serum creatinine levels > 2mg/dL)
- Concomitant therapy medications that include corticosteroids
- Peripheral neuropathy of Grade 3 or greater or painful Grade 2
- Evidence of mucosal or internal bleeding and/or platelet refractory
- ANC < 1000 cells/mm3
- Hemoglobin < 8.0 g/dL
Show all 12Show fewer
- AST (SGOT and ALT) > 2 x ULN
- Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
- Known hypersensitivity to thalidomide or the development of erythema nodosum
- Active infection or serious co-morbid medical condition
- Pregnant or breast-feeding women
- Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma
To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.
Read the detailed description
Multiple myeloma (MM) is a common hematological malignancy in Chinese elderly population. The application of novel drugs improved the clinical outcome and survival of MM patients,even though MM remains an incurable hematological malignancy. Bortezomib is a typical one among these novel agents, its application resulted in great success, but its adverse events and high expense restricted its widely usage. Investigators modified the dose and frequency of bortezomib administration in combination therapy: Patients in the modified group received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide，while patients in the control group received similar combination therapy except with conventional bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11.
The aim of this study is to investigate whether the modified bortezomib-based therapy may attain a similar efficacy as the conventional ones.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib, Dexamethasone, Doxorubicin, Cyclophosphamide, Mitoxsnteone
- 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
DexamethasoneDrug
DoxorubicinDrug
CyclophosphamideDrug
MitoxsnteoneDrug
ThalidomideDrug
| Study group | Role | What they receive |
|---|---|---|
| modified BZ group | Experimental | Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Mitoxsnteone; Drug: Thalidomide |
| conventional BZ group | Active comparator | Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Mitoxsnteone; Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease responses to treatment
Response evaluated by changes of serum M-component(g/L) through Serum quantitative immunoglobulins and Serum immunofixation electrophoresis.
(g/L)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJul 2010
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (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 Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daolin Wei, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guohua Liu, MD, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559154
- Sponsor's protocol ID
- 2010K059
- Status last verified
- May 2018
- First submitted
- 21 Sep 2015
- Last updated
- 4 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02559154
- Acronym / sponsor ID
- 2010K059
- Conditions
- Multiple Myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Sep 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.
To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.
Detailed description
Multiple myeloma (MM) is a common hematological malignancy in Chinese elderly population. The application of novel drugs improved the clinical outcome and survival of MM patients,even though MM remains an incurable hematological malignancy. Bortezomib is a typical one among these novel agents, its application resulted in great success, but its adverse events and high expense restricted its widely usage. Investigators modified the dose and frequency of bortezomib administration in combination therapy: Patients in the modified group received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide，while patients in the control group received similar combination therapy except with conventional bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11.
The aim of this study is to investigate whether the modified bortezomib-based therapy may attain a similar efficacy as the conventional ones.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified BZ group | Experimental | Drug: Bortezomib, Drug: Dexamethasone, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Mitoxsnteone, Drug: ThalidomidePatients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide |
| conventional BZ group | Active comparator | Drug: Bortezomib, Drug: Dexamethasone, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Mitoxsnteone, Drug: ThalidomidePatients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of multiple myeloma based on standard diagnosis criteria:
- Must have relapsed or relapsed/refractory disease
- 18 years of age or older
- All baseline studies must be performed within 21 days of enrollment.
- ECOG performance status of 0 to 2
Key exclusion criteria (12 listed)
- Renal insufficiency (serum creatinine levels > 2mg/dL)
- Concomitant therapy medications that include corticosteroids
- Peripheral neuropathy of Grade 3 or greater or painful Grade 2
- Evidence of mucosal or internal bleeding and/or platelet refractory
- ANC < 1000 cells/mm3
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 | Drug | conventional BZ group, modified BZ group |
| Dexamethasone | Drug | conventional BZ group, modified BZ group |
| Doxorubicin | Drug | conventional BZ group, modified BZ group |
| Cyclophosphamide | Drug | conventional BZ group, modified BZ group |
| Mitoxsnteone | Drug | conventional BZ group, modified BZ group |
| Thalidomide | Drug | conventional BZ group, modified BZ group |
Primary outcome
disease responses to treatment
Time frame: one year
Response evaluated by changes of serum M-component(g/L) through Serum quantitative immunoglobulins and Serum immunofixation electrophoresis. (g/L)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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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.
Guohua Liu, MD study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 Bortezomib, Dexamethasone and Doxorubicin in people with Multiple Myeloma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 12 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 4 May 2018. 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?
disease responses to treatment (time frame: one year). 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 4 May 2018.