Newly Diagnosed Multiple MyelomaPhase 1/2NCT06799676
A Phase Ib/II Clinical Study on the Application of Linperlisib Combined with the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma
A Phase 1/2 study testing a combination treatment of Linperlisib and the VRD regimen in people with Newly Diagnosed Multiple Myeloma, run by Fuling Zhou at 3 sites in China.
Trial summary
This study aims to evaluate the safety and efficacy of Linperlisib combined with the VRD regimen in the treatment of newly diagnosed patients with multiple myeloma. The study is divided into a Phase Ib dose exploration phase and a Phase II expansion phase.The Phase Ib dose exploration phase primarily aims to determine… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- a combination treatment of Linperlisib and the VRD regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesChina
- Study dates
- Feb 2025to Oct 2027
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients must be newly diagnosed with active multiple myeloma. 2. Patients must be between 18 and 65 years old and eligible for autologous hematopoietic stem cell transplantation (ASCT).
- 3. Patients must have measurable disease, defined as follows:
- Any quantifiable serum monoclonal protein level (typically but not necessarily ≥0.5 g/dL of M-protein), and/or urinary light chain excretion >200 mg/24 hours.
- For oligosecretory or non-secretory multiple myeloma (MM), patients must have measurable plasmacytomas >2 cm confirmed by clinical examination or imaging (e.g., MRI, CT scan) or an abnormal free light chain (FLC) ratio (normal value: 0.26-1.65) with an involved FLC level ≥10 mg/dL.
- 4. Patients must have an expected survival of ≥3 months. 5. Karnofsky Performance Status (KPS) score must be ≥60%. 6. Liver Function:
- Serum alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN).
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- Aspartate aminotransferase (AST) ≤3 times ULN.
- Direct bilirubin ≤2 mg/dL (34 µmol/L) within 14 days prior to randomization. 7. Neutrophil and Platelet Counts: Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L within 14 days prior to randomization.Platelet count ≥75 × 10⁹/L (or ≥50 × 10⁹/L if >50% of bone marrow is involved with myeloma) within 14 days prior to randomization.
- 8. Creatinine clearance (CrCl) ≥30 mL/min, measured or calculated using standard formulas (e.g., Cockcroft-Gault) within 7 days prior to randomization.
- 9. Corrected serum calcium levels must be ≤14 mg/dL (3.5 mmol/L). 10. Left ventricular ejection fraction (LVEF) must be ≥40%. Two-dimensional transthoracic echocardiography (ECHO) is the preferred method for assessment. If ECHO is unavailable, a multigated acquisition scan (MUGA) is acceptable.
- 11. Patients must be able to understand and voluntarily sign the informed consent form.
- 12. Women with childbearing potential must agree to undergo pregnancy testing and use contraception.
- 13. Male subjects must agree to use contraception.
Who cannot join
- 1. Patients who have previously received anti-myeloma therapy, except for radiotherapy, bisphosphonates, or a single short course of steroids (≤40 mg/day of dexamethasone equivalent for up to 4 days).
- 2. Non-secretory MM patients, unless they have abnormal serum free light chains or a measurable plasmacytoma with a minimum maximum diameter >2 cm.
- 3. Patients who do not meet the eligibility criteria for autologous stem cell transplantation.
- 4. Women who are pregnant or breastfeeding. 5. Acute active infections requiring treatment (ongoing use of systemic antibiotics, antiviral, or antifungal agents) within 14 days prior to randomization.
- 6. Patients with known human immunodeficiency virus (HIV) infection. 7. Active hepatitis A, B, or C infection. 8. Patients with the following cardiac conditions within 4 months prior to randomization:
- Unstable angina or myocardial infarction.
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- New York Heart Association (NYHA) Class III or IV heart failure.
- Uncontrolled angina.
- Severe coronary artery disease.
- Severe ventricular arrhythmias.
- Sick sinus syndrome.
- Acute ischemia.
- Electrocardiographic evidence of Grade 3 conduction abnormalities, unless the patient has a pacemaker.
- 9. Severe neuropathy (Grade 3-4 or Grade 2 with pain) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC) Version 4.0 within 14 days prior to randomization.
- 10. Known allergy to any of the investigational drugs. 11. Patients with contraindications to required concomitant medications or supportive therapies, including hypersensitivity to all anticoagulants, antiplatelets, or antiviral agents, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
- 12. Any other clinically significant disease or condition that, in the investigator's opinion, could interfere with protocol adherence or the patient's ability to provide informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Fuling Zhou, director, +86-02767813137, zhoufuling@whu.edu.cn
Xianning Central Hospital
Xianning, Hubei, 437100
RenYing Ge
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Chong Wang
About this study
Official title: A Single-Arm, Multicenter, Open-Label Phase Ib/II Clinical Study on the Application of Linperlisib Plus the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma
This study aims to evaluate the safety and efficacy of Linperlisib combined with the VRD regimen in the treatment of newly diagnosed patients with multiple myeloma. The study is divided into a Phase Ib dose exploration phase and a Phase II expansion phase.The Phase Ib dose exploration phase primarily aims to determine the recommended Phase II dose (RP2D) of Linperlisib based on dose-limiting toxicity (DLT). The Phase II expansion phase involves induction therapy using at least four cycles of Linperlisib at RP2D in combination with the VRD regimen. After completing four cycles of induction therapy, patients eligible for autologous hematopoietic stem cell transplantation (ASCT) will undergo the procedure. For patients whose therapeutic evaluation results in PD (progressive disease) or SD (stable disease), alternative treatment regimens will be considered based on their condition. After successful transplantation, 2-4 cycles of the original induction regimen will be used for consolidation therapy.The primary objective is to evaluate the proportion of patients achieving a very good partial response (VGPR) after four cycles of induction therapy with the Linperlisib combined VRD regimen.
- Conditions
- Newly Diagnosed Multiple Myeloma
- Being tested
- a combination treatment of Linperlisib and the VRD regimen
- Keywords
- multiple myeloma, PI3Kδ inhibitor, Linperlisib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a combination treatment of Linperlisib and the VRD regimenDrug
Subjects will be administered Linperlisib orally at doses of 40 mg, 60 mg, or 80 mg once daily for 4 consecutive weeks, combined with the VRD regimen at standard doses. Subsequently, during the expansion phase, at least four cycles of Linperlisib at the recommended Phase II dose (RP2D) will be combined with the VRD regimen for induction therapy.
| Study group | Role | What they receive |
|---|---|---|
| enrollment cohort | Experimental | Phase Ib ：Subjects will be administered Linperlisib orally at doses of 40 mg, 60 mg, or 80 mg once daily for 4 consecutive weeks, combined with the standard-dose VRD regimen. The dose-limiting toxicity (DLT) observation period is set at 28 days. If no DLT or other serious adverse events (SAEs) related to the investigational drug occur during the DLT observation period, the subject will proceed to subsequent treatment. In the absence of serious adverse events related to the investigational drug, the dose will be escalated to the next cohort based on the dose escalation principle.
The Phase II expansion phase involves induction therapy with at least four cycles of Linperlisib at the recommended Phase II dose (RP2D) in combination with the VRD regimen. After completing four cycles of induction therapy, patients who meet the criteria for autologous hematopoietic stem cell transplantation (ASCT) will undergo the procedure. If a patient's therapeutic evaluation results in progressive disea Receives: Drug: a combination treatment of Linperlisib and the VRD regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
The primary objective is to determine the recommended Phase II dose (RP2D) of Linperlisib based on dose-limiting toxicity (DLT).
Measured: At the end of Cycle 4 (each cycle is 28 days)
VGPR Rate
The very good partial response (VGPR) rate is evaluated based on the 2016 International Myeloma Working Group (IMWG) criteria.
Measured: At the end of Cycle 4 (each cycle is 28 days)
Secondary outcomes (4)
Complete remission rate
Bone marrow primitive cells <5%, no primitive cells with Auer vesicles, no primitive cells in the peripheral blood, no extramedullary leukaemia, neutrophil count ≥1.0×109/L, platelet count ≥100×109/L
Measured: At the end of Cycle 4 (each cycle is 28 days)
Overall survival
The time from the patient's first dose of medication to the time of death from any cause.
Measured: Time from the patient's first dose of medication to death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
Progression-Free Survival (PFS)
The length of time during and after treatment that a patient lives without any signs of disease progression, assessed after completing induction therapy, ASCT, and consolidation therapy.
Measured: Time from the patient's first dose of medication to death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
Incidence of adverse events
Incidence of adverse events, e.g., GI adverse reactions, cardiotoxicity, etc.
Measured: At the end of Cycle 4 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuling Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fuling Zhou, Zhongnan Hospital
- Investigators
- Fuling Zhou, Study director, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799676
- Sponsor's protocol ID
- 0101
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 29 Jan 2025
- 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 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Open-Label Phase Ib/II Clinical Study on the Application of Linperlisib Plus the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06799676
- Acronym / sponsor ID
- 0101
- Conditions
- Newly Diagnosed Multiple Myeloma
- Keywords
- multiple myeloma, PI3Kδ inhibitor, Linperlisib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fuling ZhouUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Jan 2025 (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 aims to evaluate the safety and efficacy of Linperlisib combined with the VRD regimen in the treatment of newly diagnosed patients with multiple myeloma. The study is divided into a Phase Ib dose exploration phase and a Phase II expansion phase.The Phase Ib dose exploration phase primarily aims to determine the recommended Phase II dose (RP2D) of Linperlisib based on dose-limiting toxicity (DLT). The Phase II expansion phase involves induction therapy using at least four cycles of Linperlisib at RP2D in combination with the VRD regimen. After completing four cycles of induction therapy, patients eligible for autologous hematopoietic stem cell transplantation (ASCT) will undergo the procedure. For patients whose therapeutic evaluation results in PD (progressive disease) or SD (stable disease), alternative treatment regimens will be considered based on their condition. After successful transplantation, 2-4 cycles of the original induction regimen will be used for consolidation therapy.The primary objective is to evaluate the proportion of patients achieving a very good partial response (VGPR) after four cycles of induction therapy with the Linperlisib combined VRD regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enrollment cohort | Experimental | Drug: a combination treatment of Linperlisib and the VRD regimenPhase Ib ：Subjects will be administered Linperlisib orally at doses of 40 mg, 60 mg, or 80 mg once daily for 4 consecutive weeks, combined with the standard-dose VRD regimen. The dose-limiting toxicity (DLT) observation period is set at 28 days. If no DLT or other serious adverse events (SAEs) related to the investigational drug occur during the DLT observation period, the subject will proceed to subsequent treatment. In the absence of serious adverse events related to the investigational drug, the dose will be escalated to the next cohort based on the dose escalation principle. The Phase II expansion phase involves induction therapy with at least four cycles of Linperlisib at the recommended Phase II dose (RP2D) in combination with the VRD regimen. After completing four cycles of induction therapy, patients who meet the criteria for autologous hematopoietic stem cell transplantation (ASCT) will undergo the procedure. If a patient's therapeutic evaluation results in progressive disea |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1.Patients must be newly diagnosed with active multiple myeloma. 2. Patients must be between 18 and 65 years old and eligible for autologous hematopoietic stem cell transplantation (ASCT).
- Any quantifiable serum monoclonal protein level (typically but not necessarily ≥0.5 g/dL of M-protein), and/or urinary light chain excretion >200 mg/24 hours.
- For oligosecretory or non-secretory multiple myeloma (MM), patients must have measurable plasmacytomas >2 cm confirmed by clinical examination or imaging (e.g., MRI, CT scan) or an abnormal free light chain (FLC) ratio (normal value: 0.26-1.65) with an involved FLC level ≥10 mg/dL.
- 4. Patients must have an expected survival of ≥3 months. 5. Karnofsky Performance Status (KPS) score must be ≥60%. 6. Liver Function:
- Serum alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN).
Key exclusion criteria (16 listed)
- 1. Patients who have previously received anti-myeloma therapy, except for radiotherapy, bisphosphonates, or a single short course of steroids (≤40 mg/day of dexamethasone equivalent for up to 4 days).
- 2. Non-secretory MM patients, unless they have abnormal serum free light chains or a measurable plasmacytoma with a minimum maximum diameter >2 cm.
- 3. Patients who do not meet the eligibility criteria for autologous stem cell transplantation.
- 4. Women who are pregnant or breastfeeding. 5. Acute active infections requiring treatment (ongoing use of systemic antibiotics, antiviral, or antifungal agents) within 14 days prior to randomization.
- 6. Patients with known human immunodeficiency virus (HIV) infection. 7. Active hepatitis A, B, or C infection. 8. Patients with the following cardiac conditions within 4 months prior to randomization:
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 |
|---|---|---|
| a combination treatment of Linperlisib and the VRD regimenSubjects will be administered Linperlisib orally at doses of 40 mg, 60 mg, or 80 mg once daily for 4 consecutive weeks, combined with the VRD regimen at standard doses. Subsequently, during the expansion phase, at least four cycles of Linperlisib at the recommended Phase II dose (RP2D) will be combined with the VRD regimen for induction therapy. | Drug | enrollment cohort |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: At the end of Cycle 4 (each cycle is 28 days)
The primary objective is to determine the recommended Phase II dose (RP2D) of Linperlisib based on dose-limiting toxicity (DLT).
VGPR Rate
Time frame: At the end of Cycle 4 (each cycle is 28 days)
The very good partial response (VGPR) rate is evaluated based on the 2016 International Myeloma Working Group (IMWG) criteria.
4 secondary outcomes
Complete remission rate
Time frame: At the end of Cycle 4 (each cycle is 28 days)
Overall survival
Time frame: Time from the patient's first dose of medication to death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
Progression-Free Survival (PFS)
Time frame: Time from the patient's first dose of medication to death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
Incidence of adverse events
Time frame: At the end of Cycle 4 (each cycle is 28 days)
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 29 Jan 2025.
- 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.
Fuling Zhou study director
Zhongnan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing a combination treatment of Linperlisib and the VRD regimen in people with Newly Diagnosed Multiple Myeloma, run by Fuling Zhou at 3 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 13 inclusion and 16 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: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 Fuling Zhou, Doctor (027-67813137, zhoufuling@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: At the end of Cycle 4 (each cycle is 28 days)). The study lists 2 primary outcomes in all. 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 29 Jan 2025.