Multiple MyelomaPhase 2NCT03605056
Phase 2 Trial of Chidamide-Lenalidomide-Dexamethasone(CRD) Regimen in R/R MM
A Phase 2 study testing chidamide, lenalidomide and dexamethasone in people with Multiple Myeloma, run by Peng Liu at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of combination of Chidamide-Lenalidomine-Dexamethasone in relapsed or refractory multiple myeloma 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?
- chidamide, lenalidomide 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
- 25 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2018to 31 Jul 2022
- 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
- Male or female patient ≥ age 18 years
- Patient is able to understand and has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
- Patient has been previously diagnosed with MM based on standard International Myeloma Working Group (IMWG) criteria and currently requires treatment.
- Patient must have received at least one previous line of therapy for multiple myeloma including bortezomib
- Patient must have demonstrated disease progression on or within 60 days of completion of the last therapy. Patient has measurable disease defined as at least one of the following:
- Serum M protein ≥ 0.5 g/dL (≥5 g/L)
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- Urine M protein ≥200 mg/24 hours
- Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Negative serum or urine pregnancy test for women of child-bearing potential
- Screening Laboratory parameters:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/dL (1.5 x 10^9/L). Granulocyte colony-stimulating factor (GCSF) is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
- Platelet count ≥ 70,000 cells/dL (70 x 10^9/L) Platelet transfusion is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
- Hemoglobin ≥ 8.0 g/dl ( red blood cell (RBC) transfusions are permitted during the screening period)
- Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) ; Aspartate transaminase (AST, or SGOT) and alanine transaminase (ALT, or SGPT) ≤ 2.5x ULN Estimated creatinine clearance by Cockcroft-Gault formula ≥ 50 mL/min
Who cannot join
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
- Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- Prior anti-cancer therapy within 14 days.
- Patient has any Grade 3 or > unresolved peripheral neuropathy from previous treatment.
- Patient is human immunodeficiency virus (HIV) positive,.
- Patient is Hepatitis B Surface antigen-positive or HBV-DNA copies > 10^3/ml
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- Patient has active hepatitis C infection.
- Hypersensitivity to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
- Known history of allergy to 2 or > drugs or any component of regimen
- Any clinically significant, uncontrolled medical conditions that, in the treating Investigator's opinion, would impose excessive risk to the patient or may interfere with compliance or interpretation of the study results. Uncontrolled intercurrent illness may include, but is not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations as determined by treating investigator that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chindamide in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma, a Phase II Trial
The purpose of this study is to evaluate the safety and effectiveness of combination of Chidamide-Lenalidomine-Dexamethasone in relapsed or refractory multiple myeloma patients
- Conditions
- Multiple Myeloma
- Being tested
- chidamide, lenalidomide, 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.
chidamideDrug
Also called Epidaza, CS055, HBI-8000
20 mg/d, will be administered orally, on Days 1, 4, 8, 11 of each 21 day cycle
lenalidomideDrug
25 mg/d, will be administered orally on Days 1-14 each 21 day cycle
dexamethasoneDrug
40mg weekly, will be administered orally or intravenously
| Study group | Role | What they receive |
|---|---|---|
| CRD regimen | Experimental | CRD is a new 3-drug regimen adding a HDACi named chidamide to a novel 2-drug combination of lenalidomide and dexamethasone (RD) Receives: Drug: chidamide; Drug: lenalidomide; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
according to IMWG criteria, including the rate of complete remission (CR), very good partial remission (VGPR) and partial remission (PR)
Measured: 2 years
Secondary outcomes (2)
Number of participants with treatment-related adverse events
as assessed by CTCAE v4.0
Measured: 2 years
Overall Survival Rate
The percentage of people in the study group who are still alive 2 years after the start of treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start31 Jul 2018 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2022 (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
- Not applicable
- Intervention model
- Single group
- Model description
- All the patients involved in this study will receive a 3-drug regimen (chindamide, lenalidomide and dexamethasone)
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peng Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Chipscreen Biosciences, Ltd.
- Responsible party
- Sponsor-investigator, Peng Liu, Shanghai Zhongshan Hospital
- Investigators
- Peng Liu, MD,PhD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605056
- Sponsor's protocol ID
- SHZS-MM001
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chindamide in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma, a Phase II Trial
- ClinicalTrials.gov ID
- NCT03605056
- Acronym / sponsor ID
- SHZS-MM001
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Peng LiuUniversity, hospital or other
- Collaborators
- Chipscreen Biosciences, Ltd.
- Study start
- 31 Jul 2018 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 30 Jul 2018 (actual)
- 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 combination of Chidamide-Lenalidomine-Dexamethasone in relapsed or refractory multiple myeloma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the patients involved in this study will receive a 3-drug regimen (chindamide, lenalidomide and dexamethasone)
| Arm | Type | Receives |
|---|---|---|
| CRD regimen | Experimental | Drug: chidamide, Drug: lenalidomide, Drug: dexamethasoneCRD is a new 3-drug regimen adding a HDACi named chidamide to a novel 2-drug combination of lenalidomide and dexamethasone (RD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female patient ≥ age 18 years
- Patient is able to understand and has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
- Patient has been previously diagnosed with MM based on standard International Myeloma Working Group (IMWG) criteria and currently requires treatment.
- Patient must have received at least one previous line of therapy for multiple myeloma including bortezomib
- Patient must have demonstrated disease progression on or within 60 days of completion of the last therapy. Patient has measurable disease defined as at least one of the following:
Key exclusion criteria (10 listed)
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
- Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- Prior anti-cancer therapy within 14 days.
- Patient has any Grade 3 or > unresolved peripheral neuropathy from previous treatment.
- Patient is 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 |
|---|---|---|
| chidamideAlso: Epidaza, CS055, HBI-800020 mg/d, will be administered orally, on Days 1, 4, 8, 11 of each 21 day cycle | Drug | CRD regimen |
| lenalidomide25 mg/d, will be administered orally on Days 1-14 each 21 day cycle | Drug | CRD regimen |
| dexamethasone40mg weekly, will be administered orally or intravenously | Drug | CRD regimen |
Primary outcome
Response Rate
Time frame: 2 years
according to IMWG criteria, including the rate of complete remission (CR), very good partial remission (VGPR) and partial remission (PR)
2 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 2 years
Overall Survival Rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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.
Peng Liu, MD,PhD principal investigator
Shanghai Zhongshan 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 chidamide, lenalidomide and dexamethasone in people with Multiple Myeloma, run by Peng Liu 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 15 inclusion and 10 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 30 Jul 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 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?
Contact Zheng Wei, MD (00862164041990 ext. 2925, wei.zheng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 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 30 Jul 2018.