Multiple Myeloma in RelapsePhase 2NCT06255847
Clinical Study of Reduced-dose Pomalidomide and Cyclophosphamide Combined With Dexamethasone in the Treatment of Patients With Debilitating RRMM
A Phase 2 study testing Pomalidomide, cyclophosphamide combined with dexametha in people with Multiple Myeloma in Relapse, run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
This is an open-label clinical study to evaluate the efficacy and safety of a multicenter, open-label clinical study of a base-reduced-dose pomalidomide, cyclophosphamide combined with dexamethasone (PCd) regimen for the treatment of patients with debilitating relapsed refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse
- What is being tested?
- Pomalidomide, cyclophosphamide combined with dexametha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 15 Jun 2025
- 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
- Age ≥ 18 years;
- Patients with relapsed/refractory MM, including extramedullary infiltration (meeting IMWG 2016 diagnostic criteria);
- IMWG frailty assessment: frail patients.
- Patients with multiple myeloma who have relapsed after previous treatment with 1-3 regimens;
- Patients unresponsive or unable to undergo autologous stem cell transplantation and with disease progression or resistance after prior treatment with proteasome-containing inhibitors (bortezomib) or immunomodulators (thalidomide, lenalidomide); tolerant to more than one of the above drugs;
- Serum monoclonal protein (M protein) reaches measurable levels: serum M protein ≥ 5 g/L; or 24h urinary light chain > 200mg; or serum free light chain > 10mg/dL;
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- The patient's clinical indicators must meet the following criteria:ANC ≥ 1.0 x 109/L and PLT ≥ 75 x 109/L for myeloma cells < 50%; any ANC and PLT ≥ 50 x 109 for myeloma cells ≥ 50%; platelets or granulocyte colony-stimulating factor (G-CSF) may be infused to help patients meet the eligibility criteria, but are not permitted within the first 3 days of enrollment; Patients with a glomerular filtration rate ≥10 mL/min who do not require dialysis;
- Patients who have not undergone major surgery, radiation therapy, or participated in another research trial within 2 weeks and have recovered from clinical toxicity of prior therapy;
- with follow-up conditions. Patients understand the characteristics of the disease they suffer from and voluntarily enroll in this study protocol for treatment and follow-up;
- Informed consent has been signed. Informed consent was signed by the patient himself/herself or his/her immediate family members. From the patient's condition, if the patient's own signature is not conducive to the treatment of the condition, then the legal guardian or the patient's immediate family members will sign the informed consent.
Who cannot join
- Patients with newly diagnosed multiple myeloma (NDMM), plasma cell leukemia;
- Previous use of pomalidomide, cyclophosphamide;
- patients with cyclophosphamide, dexamethasone allergy/intolerance;
- patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired and congenital immunodeficiency diseases;
- hepatic insufficiency (bilirubin > 3.1mg/100m, ALT and AST > 2 times the upper limit of normal value);
- The presence of severe thrombotic events before treatment;
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- Patients with comorbid uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) defined class III-IV heart failure, uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis;
- Infection requiring systemic antibiotic therapy, or other serious infection within 14 days;
- Those who underwent major surgery within 30 days prior to enrollment;
- those who require medication for epilepsy, dementia and other abnormal mental conditions who are unable to understand or comply with the study protocol;
- Patients with serious physical or mental illnesses that, in the judgment of the protocol or the investigator, are likely to interfere with participation in this clinical study;
- Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or the evaluation of study results;
- persons who, in the opinion of the investigator, are not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ShanxiBethuneH
Taiyuan, Shanxi, 030032
Weiwei Tian, +8613485304136, tianweiwei@yeah.net
About this study
Official title: A Multicenter, Open-label Clinical Study of a Reduced-dose Pomalidomide and Cyclophosphamide Combined With Dexamethasone Regimen for the Treatment of Patients With Debilitating Relapsed-refractory Multiple Myeloma
This is an open-label clinical study to evaluate the efficacy and safety of a multicenter, open-label clinical study of a base-reduced-dose pomalidomide, cyclophosphamide combined with dexamethasone (PCd) regimen for the treatment of patients with debilitating relapsed refractory multiple myeloma.
Subjects meeting the enrollment criteria were screened for entry into the study and treated with the appropriate regimen; all patients enrolled in the study did not receive medications other than those specified in the regimen for the treatment of myeloma during the study period, except for supportive care. The primary endpoint of the study is ORR; secondary study endpoints include efficacy above VGPR, progression-free survival (PFS), overall survival (OS), TTNT, safety, and life scale assessment.
- Conditions
- Multiple Myeloma in Relapse
- Being tested
- Pomalidomide, cyclophosphamide combined with dexametha
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide, cyclophosphamide combined with dexamethaDrug
The starting dose of pomalidomide was 2 mg in all cases，the starting dose of cyclophosphamide was 50 mg/day.If the adverse event is attributable to a specific study drug, the dose is reduced accordingly for that drug; if the adverse event is associated with multiple drugs, the dose is reduced appropriately for one of the predominantly associated drugs at the discretion of the investigator; and if multiple adverse events occur concurrently, the dose should be adjusted according to the guidelines for the most severe toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Reduced-dose pomalidomide/cyclophosphamide/dexamethasone (PCd) regimen group | Experimental | Not described Receives: Drug: Pomalidomide, cyclophosphamide combined with dexametha |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall Response Rate
Measured: up to 12 months
Secondary outcomes (6)
Efficacy above VGPR
Stringent complete response is defined as fulfilling the criteria for CR combined with a normal serum free light chain ratio and the absence of clonal plasma cells in the bone marrow as confirmed by immunohistochemistry.
CR is negative serum and urine immunofixation electrophoresis, disappearance of soft tissue plasmacytomas, and <5% plasma cells in the bone marrow.
Very good partial response (VPR) is a serum protein electrophoresis with no detectable M protein, but serum and urine immunofixation electrophoresis are still positive; or a reduction in M protein of ≥90% and urinary M protein <100mg/24h.
Measured: up 3 years
PFS
progression-free survival (within 2 years)
Measured: within 2 years
OS
overall survival
Measured: up to 2 years
duration from start of study treatment with all 3 agents to start of any new line of treatment
Measured: up to 3 years
safety of drugs
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and EORTC QLQ-C30.
Measured: up to 2 years
life scale assessment above VGPR（very good partial response）
EORTC QLQ-C30 (1-3 months/dose)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Jun 2022
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies 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
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaomin Zhang, Principal investigator, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255847
- Sponsor's protocol ID
- YXLL-2022-073
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Clinical Study of a Reduced-dose Pomalidomide and Cyclophosphamide Combined With Dexamethasone Regimen for the Treatment of Patients With Debilitating Relapsed-refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06255847
- Acronym / sponsor ID
- YXLL-2022-073
- Conditions
- Multiple Myeloma in Relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 13 Feb 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 is an open-label clinical study to evaluate the efficacy and safety of a multicenter, open-label clinical study of a base-reduced-dose pomalidomide, cyclophosphamide combined with dexamethasone (PCd) regimen for the treatment of patients with debilitating relapsed refractory multiple myeloma.
Subjects meeting the enrollment criteria were screened for entry into the study and treated with the appropriate regimen; all patients enrolled in the study did not receive medications other than those specified in the regimen for the treatment of myeloma during the study period, except for supportive care. The primary endpoint of the study is ORR; secondary study endpoints include efficacy above VGPR, progression-free survival (PFS), overall survival (OS), TTNT, safety, and life scale assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced-dose pomalidomide/cyclophosphamide/dexamethasone (PCd) regimen group | Experimental | Drug: Pomalidomide, cyclophosphamide combined with dexametha |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years;
- Patients with relapsed/refractory MM, including extramedullary infiltration (meeting IMWG 2016 diagnostic criteria);
- IMWG frailty assessment: frail patients.
- Patients with multiple myeloma who have relapsed after previous treatment with 1-3 regimens;
- Patients unresponsive or unable to undergo autologous stem cell transplantation and with disease progression or resistance after prior treatment with proteasome-containing inhibitors (bortezomib) or immunomodulators (thalidomide, lenalidomide); tolerant to more than one of the above drugs;
Key exclusion criteria (13 listed)
- Patients with newly diagnosed multiple myeloma (NDMM), plasma cell leukemia;
- Previous use of pomalidomide, cyclophosphamide;
- patients with cyclophosphamide, dexamethasone allergy/intolerance;
- patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired and congenital immunodeficiency diseases;
- hepatic insufficiency (bilirubin > 3.1mg/100m, ALT and AST > 2 times the upper limit of normal value);
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 |
|---|---|---|
| Pomalidomide, cyclophosphamide combined with dexamethaThe starting dose of pomalidomide was 2 mg in all cases，the starting dose of cyclophosphamide was 50 mg/day.If the adverse event is attributable to a specific study drug, the dose is reduced accordingly for that drug; if the adverse event is associated with multiple drugs, the dose is reduced appropriately for one of the predominantly associated drugs at the discretion of the investigator; and if multiple adverse events occur concurrently, the dose should be adjusted according to the guidelines for the most severe toxicity. | Drug | Reduced-dose pomalidomide/cyclophosphamide/dexamethasone (PCd) regimen group |
Primary outcome
ORR
Time frame: up to 12 months
Overall Response Rate
6 secondary outcomes
Efficacy above VGPR
Time frame: up 3 years
PFS
Time frame: within 2 years
OS
Time frame: up to 2 years
duration from start of study treatment with all 3 agents to start of any new line of treatment
Time frame: up to 3 years
safety of drugs
Time frame: up to 2 years
life scale assessment above VGPR（very good partial response）
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
Xiaomin Zhang principal investigator
Shanxi Bethune 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 Pomalidomide, cyclophosphamide combined with dexametha in people with Multiple Myeloma in Relapse, run by Shanxi Bethune Hospital 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 10 inclusion and 13 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 13 Feb 2024. 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 Weiwei Tian, Doctor (+8613485304136, 408933582@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 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 13 Feb 2024.