Multiple MyelomaNCT06697483
Risk Stratification and MRD-driven Maintenance for MM After ASCT
A study testing Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Peking University People's Hospital at 4 sites in China.
Trial summary
This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation. This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. 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?
- Daratumumab and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 1 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT.
- Must have a partial response (PR) or better response before maintenance.
- Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
- This study allows for post-ASCT consolidation therapy.
- ANC ≥ 1.0 x 10^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10^9/L (if BMPC < 50%) or PLT ≥ 50 x 10^9/L (if BMPC ≥ 50%).
- No active infection.
- a).TBIL<1.5 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b).AST and ALT <3 x ULN.; c. Creatinine clearance ≥ 45mL/min.
Who cannot join
- Must not refractory or non-tolerate to lenalidomide in Arm A.
- Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
- Must not have progressed on multiple myeloma (MM) therapy before screening
- Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
- Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
- History of stroke or serious thrombotic event within 12 months prior to screening.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Fuxing Hospital
Beijing, Beijing Municipality, 100038
Liru Wang, M.D., wanglirumail@126.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100044
Jinling Zhuang, M.D., 86-13910118511, zhuangjunling@hotmail.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yang Liu, 86-13716926210, pkuphliuyang@bjmu.edu.cn
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Yanqiu Zhao, 86-17745672811, 17745672811@163.com
About this study
Official title: Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation
This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation.
This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab, Lenalidomide
- Keywords
- R2-ISS stage, Minimal Residual Disease, Lenalidomide, Daratumumab
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.
LenalidomideDrug
Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation.
Patients will receive the single drug lenalidomide maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Other | For patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance Receives: Drug: Lenalidomide |
| Daratumumab and Lenalidomide | Other | For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance Receives: Drug: Daratumumab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD (Minimal Residual Disease) status at 12 months after maintenance
Bone marrow minimal residual disease status at 12 months after maintenance
Measured: 12 months
Secondary outcomes (4)
CR+VGPR
complete response plus very good partial response at 12 months from maintenance
Measured: 12 months
Estimated 3 year-PFS
Estimated 3 year progression free survival
Measured: 3 years
Estimated 3 year OS
Estimated 3 year overall survival
Measured: 3 years
TRAEs
Treatment related adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697483
- Sponsor's protocol ID
- 2024PHB165-001-20240930
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06697483
- Acronym / sponsor ID
- 2024PHB165-001-20240930
- Conditions
- Multiple Myeloma
- Keywords
- R2-ISS stage, Minimal Residual Disease, Lenalidomide, Daratumumab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Nov 2024 (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.
This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation.
This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Other | Drug: LenalidomideFor patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance |
| Daratumumab and Lenalidomide | Other | Drug: Daratumumab, Drug: LenalidomideFor patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT.
- Must have a partial response (PR) or better response before maintenance.
- Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
- This study allows for post-ASCT consolidation therapy.
- ANC ≥ 1.0 x 10^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10^9/L (if BMPC < 50%) or PLT ≥ 50 x 10^9/L (if BMPC ≥ 50%).
Key exclusion criteria (6 listed)
- Must not refractory or non-tolerate to lenalidomide in Arm A.
- Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
- Must not have progressed on multiple myeloma (MM) therapy before screening
- Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
- Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
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 |
|---|---|---|
| DaratumumabPatients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance. | Drug | Daratumumab and Lenalidomide |
| LenalidomidePatients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation. Patients will receive the single drug lenalidomide maintenance. | Drug | Daratumumab and Lenalidomide, Lenalidomide |
Primary outcome
MRD (Minimal Residual Disease) status at 12 months after maintenance
Time frame: 12 months
Bone marrow minimal residual disease status at 12 months after maintenance
4 secondary outcomes
CR+VGPR
Time frame: 12 months
Estimated 3 year-PFS
Time frame: 3 years
Estimated 3 year OS
Time frame: 3 years
TRAEs
Time frame: 3 years
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 25 Nov 2024.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Peking University People's Hospital at 4 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 7 inclusion and 6 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Yang Dr, M.D. (+86-10-88326542, pkuphliuyang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD (Minimal Residual Disease) status at 12 months after maintenance (time frame: 12 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 25 Nov 2024.