Multiple MyelomaCHAMPION-01NCT07663253
Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients
An observational study of Multiple Myeloma, run by Shanghai Zhongshan Hospital at 13 sites in China.
Trial summary
Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China. 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?
- Isatuximab, Bortezomib and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 333 participants
- Where
- 13 sitesChina
- Study dates
- Jun 2026to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients (≥18 years old) with newly diagnosed multiple myeloma, ineligible for autologous stem cell transplantation due to age or comorbidities, who are scheduled to receive the Isatuximab + Bortezomib + Lenalidomide + Dexamethasone (Isa-VRd) combination regimen.
Who may be able to join
- Age ≥18 years
- Newly diagnosed transplant-ineligible multiple myeloma patients as assessed by investigator, specifically referring to CSCO guidelines
- Must meet corresponding laboratory test results (refer to restrictions in package inserts of combination drugs):
- Absolute neutrophil count (ANC) ≥1.0×10⁹/L
- Platelet count ≥50×10⁹/L
- Calculated creatinine clearance ≥30 mL/min (using Cockcroft-Gault formula)
- Total bilirubin ≤3× upper limit of normal (ULN)
- TI-NDMM patients intended for Isa-VRd regimen treatment as determined by investigator judgment, independent of study objectives Signed informed consent form (by patient or their legal representative)
Who cannot join
- Patients currently participating in other interventional clinical studies
- Patients with known severe hypersensitivity reactions to Isatuximab or any other excipients
- Severe bacteremia at the time of administration
- Currently uncontrolled cardiovascular disease, including:
- Uncontrolled hypertension
- Uncontrolled arrhythmia
Show all 12Show fewer
- Uncontrollable congestive heart failure
- Unstable angina
- Patients with peripheral neuropathy ≥Grade 2
- Active infectious disease, known human immunodeficiency virus (HIV) positivity, active hepatitis B or hepatitis C
- Patients who are currently pregnant
- Patients who, at the physician's discretion, are unable to tolerate any drug in the combination regimen
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jiadai Xu contact
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Junling Zhuang, zhuangjunling@pumch.cn
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Xiaobing Huang, huangxiaobing@med.uestc.edu.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Zhongjun Xia, xiazhj@sysucc.org.cn
- Recruiting
Harbin Institute of Hematologic Oncology
Harbin, Heilongjiang
Tiejun Gong, gongtiejun678@163.com
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Mingxia Shi, shmxia2002@sina.com
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Naning, Guangxi, 450000
Jun Luo, luojungz@medmail.com.cn
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Xiaoyan Qu, quxiaoyan@jsph.org.cn
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Hongming Huang, hhmmmc@163.com
- Recruiting
Fudan University Affiliated Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Peng Liu, +86-021-64041990, liu.peng@zs-hospital.sh.cn
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Jihao Zhou, zhoujihao@aliyun.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
Wuhan, Hubei
Chunrui Li, cunrui5650@hust.edu.cn
- Recruiting
Xijing Hospital, Air Force Medical University
Xi’an, Shanxi
Guangxun Gao, gaoguangxun@fmmu.edu.cn
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Baijun Fang, zlyyfangbaijun1051@zzu.edu.cn
About this study
Official title: A Single-Arm, Multicenter, Prospective, Observational Clinical Study on the Efficacy and Safety of Isatuximab Combined With Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Regimen in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI-NDMM) Patients
Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China.
And Secondary Objectives is， To assess the MRD negativity rate in Chinese TI-NDMM patients treated with Isa-VRd To assess the safety and tolerability of Isa-VRd in Chinese TI-NDMM patients
Read more
Participants will:
Receive Isatuximab 10 mg/kg iv
- Cycle 1: Every weeks on Days 1, 8, 15, and 22
- Cycles 2-8: Every 2 weeks on Days 1 and 15 Receive Bortezomib subcutaneous injection 1.3 mg/m²
- Cycles 1-8: Days 1, 8, and 15 of each cycle Receive Lenalidomide oral 25 mg/day
- Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Receive Dexamethasone oral 20 mg
- Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment.
During the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment.
During the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to observe the depth of response.
Read the detailed description
This is a single-arm, multicenter, prospective observational cohort study with a planned total enrollment of 333 transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients aged ≥18 years old in China. All enrolled participants will receive the Isa-VRd induction regimen for 8 cycles (4 weeks per cycle, total 32 weeks). After induction therapy, investigators will determine whether patients continue maintenance treatment based on individual response status, followed by a 2-year long-term follow-up period from the initiation of Isa-VRd treatment, with the maximum observation window of each subject capped at 24 months.
For efficacy evaluation, minimal residual disease (MRD) testing with a cutoff of NGF=10-⁵ will be performed at multiple prespecified time points: at month 8 post-induction, and every 6 months throughout the maintenance and follow-up phase (at months 14, 20 and 26). The primary endpoint of this study is ≥CR rate after induction therapy. Secondary efficacy endpoints include stringent complete response (sCR), very good partial response (VGPR), overall response rate (ORR), duration of response (DOR), time to response (TTR), time to next treatment (TNT), progression-free survival (PFS), overall survival (OS), as well as all safety and tolerability outcomes.
Throughout the entire treatment and follow-up period, all treatment-emergent adverse events (TEAEs), grade ≥3 adverse events, serious adverse events (SAEs), and adverse events of special interest (AESIs, including infusion reactions and second primary malignancies) will be continuously collected and recorded to evaluate the real-world safety profile of the Isa-VRd regimen in Chinese TI-NDMM patients. The overall planned study duration spans approximately 24 months from the first subject's enrollment to the completion of the last patient's 24-month follow-up assessment.
- Conditions
- Multiple Myeloma
- Being tested
- Isatuximab, Bortezomib, Lenalidomide, Dexamethasone
- Keywords
- isatuximab, transplant-ineligible newly diagnosed multiple myeloma, TI NDMM, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Also called sarclisa
Isatuximab 10 mg/kg Intravenous (IV) infusion
- Cycle 1: Every weeks on Days 1, 8, 15, and 22
- Cycles 2-8: Every 2 weeks on Days 1 and 15 Following Cycle 8, the investigator may assess and adjust the treatment regimen Prior to administration of this product, premedication should be given 15-60 minutes before use: acetaminophen 650 mg to 1000 mg orally, H2 receptor antagonist, and diphenhydramine 25 mg to 50 mg intravenously or orally.
BortezomibDrug
Also called Velcade, PS-341
Bortezomib subcutaneous injection 1.3 mg/m²
- Cycles 1-8: Days 1, 8, and 15 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen
LenalidomideDrug
Also called Revlimid
Lenalidomide oral 25 mg/day
- Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Following Cycle 8, the investigator may assess and adjust the treatment regimen
DexamethasoneDrug
Also called Decadron
Dexamethasone oral 20 mg
- Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen
| Study group | Role | What they receive |
|---|---|---|
| Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen | Arm Description:
Isatuximab 10 mg/kg Intravenous injection
* Cycle 1: Every weeks on Days 1, 8, 15, and 22
* Cycles 2-8: Every 2 weeks on Days 1 and 15 Bortezomib subcutaneous injection 1.3 mg/m²
* Cycles 1-8: Days 1, 8, and 15 of each cycle Lenalidomide oral 25 mg/day
* Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Dexamethasone oral 20 mg
* Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen Receives: Drug: Isatuximab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥CR rate after induction treatment
The combined proportion of patients achieving stringent complete response (sCR) and complete response (CR) as assessed according to the 2016 IMWG criteria.
Measured: After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)
Secondary outcomes (9)
MRD negativity rate
Measured: At the end of induction phase (Week 32 / approximately 8 months)
≥VGPR rate
Measured: At the end of induction phase (Week 32 / approximately 8 months)
Overall response rate
Measured: At the end of induction phase (Week 32 / approximately 8 months)
Duration of Response
Measured: From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Time to Response
Measured: Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months
Duration of Treatment
Measured: Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months
Progression free survival
Measured: Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months
Overall Survival
Measured: Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months
Incidence Adverse Events
Adverse events (AEs) include treatment-emergent adverse events (TEAEs), grade ≥3 TEAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs), defined as infusion reactions (IRs) and occurrence of second primary malignancies.
Measured: From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionSep 2030 (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 Zhongshan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Liu, Shanghai Zhongshan Hospital
- Investigators
- Peng Liu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663253
- Sponsor's protocol ID
- B2026-229
- Acronym
- CHAMPION-01
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Prospective, Observational Clinical Study on the Efficacy and Safety of Isatuximab Combined With Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Regimen in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI-NDMM) Patients
- ClinicalTrials.gov ID
- NCT07663253
- Acronym / sponsor ID
- CHAMPION-01 / B2026-229
- Conditions
- Multiple Myeloma
- Keywords
- isatuximab, transplant-ineligible newly diagnosed multiple myeloma, TI NDMM, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 23 Jun 2026 (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.
Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China.
And Secondary Objectives is， To assess the MRD negativity rate in Chinese TI-NDMM patients treated with Isa-VRd To assess the safety and tolerability of Isa-VRd in Chinese TI-NDMM patients
Participants will:
Receive Isatuximab 10 mg/kg iv
- Cycle 1: Every weeks on Days 1, 8, 15, and 22
- Cycles 2-8: Every 2 weeks on Days 1 and 15 Receive Bortezomib subcutaneous injection 1.3 mg/m²
- Cycles 1-8: Days 1, 8, and 15 of each cycle Receive Lenalidomide oral 25 mg/day
- Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Receive Dexamethasone oral 20 mg
- Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment.
During the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment.
During the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to observe the depth of response.
Detailed description
This is a single-arm, multicenter, prospective observational cohort study with a planned total enrollment of 333 transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients aged ≥18 years old in China. All enrolled participants will receive the Isa-VRd induction regimen for 8 cycles (4 weeks per cycle, total 32 weeks). After induction therapy, investigators will determine whether patients continue maintenance treatment based on individual response status, followed by a 2-year long-term follow-up period from the initiation of Isa-VRd treatment, with the maximum observation window of each subject capped at 24 months.
For efficacy evaluation, minimal residual disease (MRD) testing with a cutoff of NGF=10-⁵ will be performed at multiple prespecified time points: at month 8 post-induction, and every 6 months throughout the maintenance and follow-up phase (at months 14, 20 and 26). The primary endpoint of this study is ≥CR rate after induction therapy. Secondary efficacy endpoints include stringent complete response (sCR), very good partial response (VGPR), overall response rate (ORR), duration of response (DOR), time to response (TTR), time to next treatment (TNT), progression-free survival (PFS), overall survival (OS), as well as all safety and tolerability outcomes.
Throughout the entire treatment and follow-up period, all treatment-emergent adverse events (TEAEs), grade ≥3 adverse events, serious adverse events (SAEs), and adverse events of special interest (AESIs, including infusion reactions and second primary malignancies) will be continuously collected and recorded to evaluate the real-world safety profile of the Isa-VRd regimen in Chinese TI-NDMM patients. The overall planned study duration spans approximately 24 months from the first subject's enrollment to the completion of the last patient's 24-month follow-up assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen | – | Drug: Isatuximab, Drug: Bortezomib, Drug: Lenalidomide, Drug: DexamethasoneArm Description: Isatuximab 10 mg/kg Intravenous injection * Cycle 1: Every weeks on Days 1, 8, 15, and 22 * Cycles 2-8: Every 2 weeks on Days 1 and 15 Bortezomib subcutaneous injection 1.3 mg/m² * Cycles 1-8: Days 1, 8, and 15 of each cycle Lenalidomide oral 25 mg/day * Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Dexamethasone oral 20 mg * Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) with newly diagnosed multiple myeloma, ineligible for autologous stem cell transplantation due to age or comorbidities, who are scheduled to receive the Isatuximab + Bortezomib + Lenalidomide + Dexamethasone (Isa-VRd) combination regimen.
Key inclusion criteria (8 listed)
- Age ≥18 years
- Newly diagnosed transplant-ineligible multiple myeloma patients as assessed by investigator, specifically referring to CSCO guidelines
- Must meet corresponding laboratory test results (refer to restrictions in package inserts of combination drugs):
- TI-NDMM patients intended for Isa-VRd regimen treatment as determined by investigator judgment, independent of study objectives Signed informed consent form (by patient or their legal representative)
Key exclusion criteria (12 listed)
- Patients currently participating in other interventional clinical studies
- Patients with known severe hypersensitivity reactions to Isatuximab or any other excipients
- Severe bacteremia at the time of administration
- Currently uncontrolled cardiovascular disease, including:
- Patients with peripheral neuropathy ≥Grade 2
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 |
|---|---|---|
| IsatuximabAlso: sarclisaIsatuximab 10 mg/kg Intravenous (IV) infusion * Cycle 1: Every weeks on Days 1, 8, 15, and 22 * Cycles 2-8: Every 2 weeks on Days 1 and 15 Following Cycle 8, the investigator may assess and adjust the treatment regimen Prior to administration of this product, premedication should be given 15-60 minutes before use: acetaminophen 650 mg to 1000 mg orally, H2 receptor antagonist, and diphenhydramine 25 mg to 50 mg intravenously or orally. | Drug | Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen |
| BortezomibAlso: Velcade, PS-341Bortezomib subcutaneous injection 1.3 mg/m² • Cycles 1-8: Days 1, 8, and 15 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen | Drug | Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen |
| LenalidomideAlso: RevlimidLenalidomide oral 25 mg/day • Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Following Cycle 8, the investigator may assess and adjust the treatment regimen | Drug | Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen |
| DexamethasoneAlso: DecadronDexamethasone oral 20 mg • Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen | Drug | Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen |
Primary outcome
≥CR rate after induction treatment
Time frame: After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)
The combined proportion of patients achieving stringent complete response (sCR) and complete response (CR) as assessed according to the 2016 IMWG criteria.
9 secondary outcomes
MRD negativity rate
Time frame: At the end of induction phase (Week 32 / approximately 8 months)
≥VGPR rate
Time frame: At the end of induction phase (Week 32 / approximately 8 months)
Overall response rate
Time frame: At the end of induction phase (Week 32 / approximately 8 months)
Duration of Response
Time frame: From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Time to Response
Time frame: Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months
Duration of Treatment
Time frame: Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months
Progression free survival
Time frame: Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months
Overall Survival
Time frame: Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months
Incidence Adverse Events
Time frame: From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Jiadai Xu contact
Peng Liu principal investigator
Fudan University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Shanghai Zhongshan Hospital at 13 sites 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 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Liu (+86-021-64041990, liu.peng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥CR rate after induction treatment (time frame: After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)). 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 23 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.