Multiple MyelomaPhase 3NCT02916420
Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone in Chinese Patients With Relapsed and Refractory Multiple Myeloma
A Phase 3 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to assess the efficacy and safety of pomalidomide in combination with low-dose dexamethasone in Chinese patients with relapsed and refractory 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?
- Pomalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Jun 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a documented diagnosis of multiple myeloma
- Subjects must have received at least 2 prior therapies. Subjects must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen). Subjects must also have documented evidence of progressive disease(PD) during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry.
- Subjects must have measurable disease: serum M-protein ≥ 5 g/L or urine M-protein ≥ 200 mg/24 hours or the involved free light chain being ≥100 mg/L when serum free light chain ratio (κ/λ ratio < 0.26 or > 1.65) is abnormal
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
- Life expectancy >3 months
- For female patients,
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- naturally postmenopausal for at least 24 months, or take surgical sterilization
- Women of childbearing potential must:
- have 2 negative pregnancy tests before initiating pomalidomide. The first test should be performed within 10-14 days, and the second test within 24 hours prior to initiating pomalidomide
- commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating pomalidomide treatment, during therapy, and continuing for 4 weeks following discontinuation of pomalidomide therapy
- agree to perform the pregnancy testing during the study
- Male patients must always use a condom during any sexual contact with females of reproductive potential while taking pomalidomide and for up to 4 weeks after discontinuing pomalidomide, even if they have undergone a successful vasectomy. Meanwhile male patients taking pomalidomide must not donate sperm.
- Subjects agree not to share medication with another person
- Subjects are able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Any serious medical conditions, laboratory abnormality, or psychiatric illness that would prevent the patient from complying to the protocol or put the patient's safety at risk
- Evidence of uncontrolled cardiovascular disease, such as congestive heart failure, unstable angina, myocardial infarction within 12 months prior to enrollment
- Any of the following laboratory abnormalities:
- ANC < 1×10^9/L
- PLT < 75×10^9/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; or PLT < 30×10^9/L for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells
- Creatinine Clearance < 45 mL/min
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- AST or ALT > 3.0 x ULN
- Serum total bilirubin > 34.2 μmol/L
- Corrected serum calcium > 3.5 mmol/L
- Hemoglobin < 80g/L
- Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following:
- Basal or Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix or breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- Serious, uncontrolled medical conditions or active infection, including but not limited to HIV antibody positive, HBsAg positive and HBV DNA copies > 1 × 10^3, hepatitis C virus antibody positive, uncontrolled diabetes, patients requiring hemodialysis
- Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
- Previous therapy with pomalidomide
- Peripheral neuropathy ≥ Grade 2
- Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
- Subjects who received any of the following within the last 14 days of initiation of study treatment: plasmapheresis, major surgery, radiation therapy, or use of any anti-myeloma drug therapy
- Use of any investigational drugs within 28 days prior to enrollment
- Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis, and lupus, etc.
- Patients unable or unwilling to undergo antithrombotic prophylactic treatment
- Subjects who received an allogeneic hematopoietic stem cell transplant less than 12 months prior to enrollment
- Subjects who are planning for or eligible for hematopoietic stem cell transplant
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin
About this study
Official title: A Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone in Chinese Patients With Relapsed and Refractory Multiple Myeloma
This study aims to assess the efficacy and safety of pomalidomide in combination with low-dose dexamethasone in Chinese patients with relapsed and refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Pomalidomide, 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.
PomalidomideDrug
4mg/day, d1-d21, 28 days per cycle
DexamethasoneDrug
≤70 years,40mg/day; >70 years,20mg/day, d1、d8、d15、d22, 28 days per cycle
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Pomalidomide plus low-dose Dexamethasone Receives: Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: up to 2 years
Secondary outcomes (4)
Progression-free Survival
Measured: up to 2 years
Duration of Response
Measured: up to 2 years
Time to Response
Measured: up to 2 years
Overall Survival
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (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 Jiangsu Simcere Pharmaceutical Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, MD, Principal investigator, Blood Diseases Hospital Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916420
- Sponsor's protocol ID
- SIM-135-Ⅲ
- Status last verified
- Oct 2016
- First submitted
- 24 Sep 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone in Chinese Patients With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02916420
- Acronym / sponsor ID
- SIM-135-Ⅲ
- Conditions
- Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 27 Sep 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.
This study aims to assess the efficacy and safety of pomalidomide in combination with low-dose dexamethasone in Chinese patients with relapsed and refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Pomalidomide, Drug: DexamethasonePomalidomide plus low-dose Dexamethasone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a documented diagnosis of multiple myeloma
- Subjects must have received at least 2 prior therapies. Subjects must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen). Subjects must also have documented evidence of progressive disease(PD) during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry.
- Subjects must have measurable disease: serum M-protein ≥ 5 g/L or urine M-protein ≥ 200 mg/24 hours or the involved free light chain being ≥100 mg/L when serum free light chain ratio (κ/λ ratio < 0.26 or > 1.65) is abnormal
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
- Life expectancy >3 months
Key exclusion criteria (26 listed)
- Any serious medical conditions, laboratory abnormality, or psychiatric illness that would prevent the patient from complying to the protocol or put the patient's safety at risk
- Evidence of uncontrolled cardiovascular disease, such as congestive heart failure, unstable angina, myocardial infarction within 12 months prior to enrollment
- Any of the following laboratory abnormalities:
- Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following:
- Serious, uncontrolled medical conditions or active infection, including but not limited to HIV antibody positive, HBsAg positive and HBV DNA copies > 1 × 10^3, hepatitis C virus antibody positive, uncontrolled diabetes, patients requiring hemodialysis
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 |
|---|---|---|
| Pomalidomide4mg/day, d1-d21, 28 days per cycle | Drug | Treatment |
| Dexamethasone≤70 years,40mg/day; >70 years,20mg/day, d1、d8、d15、d22, 28 days per cycle | Drug | Treatment |
Primary outcome
Objective Response Rate
Time frame: up to 2 years
4 secondary outcomes
Progression-free Survival
Time frame: up to 2 years
Duration of Response
Time frame: up to 2 years
Time to Response
Time frame: up to 2 years
Overall Survival
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Lugui Qiu, MD principal investigator
Blood Diseases Hospital Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Jiangsu Simcere Pharmaceutical Co., Ltd. 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 14 inclusion and 26 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 2 Nov 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lugui Qiu, MD (86-022-27218738, qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: up to 2 years). 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 2 Nov 2016.