Multiple Myeloma in RelapsePhase 2NCT06158412
All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma
A Phase 2 study testing All-trans Retinoic Acid in combination with the KPD Regimen in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed 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, Multiple Myeloma, Refractory
- What is being tested?
- All-trans Retinoic Acid in combination with the KPD Regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2023to 31 Dec 2025
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Subjects must have a diagnosis of multiple myeloma based on the following criteria: (1) Monoclonal plasma cells in the bone marrow in ≥10% of patients at some point in time when the presence of plasmacytoma is confirmed by disease history or biopsy. (2) Measurable disease is defined as follows: Serum monoclonal gammaglobulin (M protein) level ≥ 5 g/L; or urinary M protein level ≥ 200 mg/24 hours; or serum immunoglobulin free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kap/lam light chain ratio.
- Diagnosis of refractory/relapsed multiple myeloma: (1) Relapse is defined as the progression of disease after an initial response (≥MR) to prior therapy 60 days after cessation of therapy. (2) Refractory disease is defined as a <25% reduction in M protein or disease progression during treatment or within 60 days of stopping treatment.
- ECOG assessment of 0, 1, or 2.
- Life expectancy of at least 3 months.
- The patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF).
Who cannot join
- Patient who currently participating or planning to participate in any interventional clinical study.
- The investigator considers the patient unsuitable for participation in this study.
- Non-secretory myeloma.
- Subjects have received antimyeloma therapy within 2 weeks or 5 pharmacokinetic half-lives, whichever is longer, prior to initiation of treatment. This includes subjects who received a cumulative dose of corticosteroids greater than or equal to a 140 mg prednisone equivalent dose or a single dose of corticosteroids greater than or equal to a 40 mg/day dexamethasone equivalent dose within 2 weeks prior to initiation of treatment.
- Subjects who have previously received an allogeneic stem cell transplant within 1 year prior to the date of enrollment and have not used immunosuppressive medications within 1 month prior to the date of enrollment.
- Inadequate bone marrow reserve as defined by a platelet count <30 x 109/L or absolute neutrophil count <1.0 x 109/L.
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- Subject has clinically significant lung disease, including: (1) Subject has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Please note that patients suspected of having COPD will be required to undergo FEV1 testing and subjects must be excluded if FEV1 is <50% of predicted normal. (2) Subjects who have had moderate or severe persistent asthma within the past 2 years or currently have any category of uncontrolled asthma. (Please note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma may participate in this study)
- Subjects with clinically significant cardiac disease, including (1) Myocardial infarction within 6 months prior to Day 1 of Cycle 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina pectoris, congestive heart failure, New York Heart Association Class III-IV). (2) Cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE], 4th Edition, Grade 4 edition grade 2 or higher) or clinically significant ECG abnormalities. (3) Screening 12-lead ECG showing a baseline QT interval (QTcF) corrected by the Friedreichian formula >470 ms.
- Severe hepatic dysfunction (total bilirubin 3 times normal or transaminases 3 times normal) unless associated with myeloma.
- Creatinine clearance <20 mL/min.
- Known allergy to components of the test product, or severe allergy or hypersensitivity to humanized products.
- The subject has a concurrent serious and/or uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, infections, hypertension, etc.) that may interfere with the study procedures or results or that, in the opinion of the investigator, may pose a risk to participation in this study.
- Subjects known to be seropositive for human immunodeficiency virus (HIV) or have active hepatitis B or C.
- History of active malignancy within the past 5 years, except squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or cured within 5 years with minimal risk of recurrence in the opinion of the local investigator, in agreement with the principal investigator.
- Subjects known or suspected of not being able to comply with the study protocol (e.g. due to alcoholism, drug dependence, or psychological disorders), or the subject has any condition that, in the investigator's belief that participation would not be in the subject's best interest (e.g., detrimental to their well-being) or would likely prevent, limit, or confound protocol-specified assessments.
- Pregnant or lactating females.
- Peripheral neuritis ≥ grade 3.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Bing Xu
Xiamen, Fujian, 361000
Zhijuan Lin, PhD, +8615960283462, zjuan_lin@126.com
Bing Xu, PhD, +8618750918842, xubingzhangjian@126.com
About this study
Official title: A Single-center, Prospective, Single-arm Clinical Study of All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma (MM)
To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
Read the detailed description
This is an open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Trans-Retinoic acid (ATRA) combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
- Being tested
- All-trans Retinoic Acid in combination with the KPD Regimen
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-trans Retinoic Acid in combination with the KPD RegimenDrug
Regimen: 1 course of treatment for 28 days until disease progression or intolerable toxicity occurs
- ATRA mg/m2/day in 2 oral doses for 3 days. The first dose of ATRA will be given in the morning, two days prior to carfilzomib administration. The last ATRA dose will be given in the evening on the day of carfilzomib administration.
- Proteasome inhibitor: Carfilzomib 27mg/m2 2 consecutive days per week x 3 weeks (20mg/m2 on day 1 and day 2 of cycle 1);
- Pomalidomide 4mg orally daily, d1-21;
- Dexamethasone given orally only on days 1, 8, 15, and 22 of each cycle; ≤75 years: 40 mg/day; >75 years: 20 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| ATRA in Combination with a KPD Regimen | Experimental | All-trans Retinoic Acid plus the KPD Regimen Receives: Drug: All-trans Retinoic Acid in combination with the KPD Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Defined as the proportion of subjects who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria.
Measured: Up to 26 months
Secondary outcomes (3)
Complete response rate (CR)
Defined as the proportion of subjects whose serum and urine immunofixation electrophoresis are negative, and there is no soft tissue plasma cell tumor, with bone marrow plasma cells<5% by the 2016 International Myeloma Working Group (IMWG) criteria.
Measured: Up to 26 months
Progression free survival (PFS)
PFS was defined as the time from the date of treatment initiation until the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first.
Measured: Up to 26 months
Overall survival (OS)
OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.
Measured: Up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start22 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 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.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing, Xu, The First Affiliated Hospital of Xiamen University
- Investigators
- Zhijuan Lin, Principal investigator, The First Aiffiliated hosptical of xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158412
- Sponsor's protocol ID
- XMDYYYXYK-08
- Status last verified
- Feb 2025
- First submitted
- 22 Nov 2023
- Last updated
- 19 Feb 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Single-arm Clinical Study of All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT06158412
- Acronym / sponsor ID
- XMDYYYXYK-08
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Dec 2023 (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.
To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
Detailed description
This is an open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Trans-Retinoic acid (ATRA) combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATRA in Combination with a KPD Regimen | Experimental | Drug: All-trans Retinoic Acid in combination with the KPD RegimenAll-trans Retinoic Acid plus the KPD Regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Subjects must have a diagnosis of multiple myeloma based on the following criteria: (1) Monoclonal plasma cells in the bone marrow in ≥10% of patients at some point in time when the presence of plasmacytoma is confirmed by disease history or biopsy. (2) Measurable disease is defined as follows: Serum monoclonal gammaglobulin (M protein) level ≥ 5 g/L; or urinary M protein level ≥ 200 mg/24 hours; or serum immunoglobulin free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kap/lam light chain ratio.
- Diagnosis of refractory/relapsed multiple myeloma: (1) Relapse is defined as the progression of disease after an initial response (≥MR) to prior therapy 60 days after cessation of therapy. (2) Refractory disease is defined as a <25% reduction in M protein or disease progression during treatment or within 60 days of stopping treatment.
- ECOG assessment of 0, 1, or 2.
- Life expectancy of at least 3 months.
Key exclusion criteria (17 listed)
- Patient who currently participating or planning to participate in any interventional clinical study.
- The investigator considers the patient unsuitable for participation in this study.
- Non-secretory myeloma.
- Subjects have received antimyeloma therapy within 2 weeks or 5 pharmacokinetic half-lives, whichever is longer, prior to initiation of treatment. This includes subjects who received a cumulative dose of corticosteroids greater than or equal to a 140 mg prednisone equivalent dose or a single dose of corticosteroids greater than or equal to a 40 mg/day dexamethasone equivalent dose within 2 weeks prior to initiation of treatment.
- Subjects who have previously received an allogeneic stem cell transplant within 1 year prior to the date of enrollment and have not used immunosuppressive medications within 1 month prior to the date of enrollment.
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 |
|---|---|---|
| All-trans Retinoic Acid in combination with the KPD RegimenRegimen: 1 course of treatment for 28 days until disease progression or intolerable toxicity occurs 1. ATRA mg/m2/day in 2 oral doses for 3 days. The first dose of ATRA will be given in the morning, two days prior to carfilzomib administration. The last ATRA dose will be given in the evening on the day of carfilzomib administration. 2. Proteasome inhibitor: Carfilzomib 27mg/m2 2 consecutive days per week x 3 weeks (20mg/m2 on day 1 and day 2 of cycle 1); 3. Pomalidomide 4mg orally daily, d1-21; 4. Dexamethasone given orally only on days 1, 8, 15, and 22 of each cycle; ≤75 years: 40 mg/day; >75 years: 20 mg/day. | Drug | ATRA in Combination with a KPD Regimen |
Primary outcome
Overall response rate (ORR)
Time frame: Up to 26 months
Defined as the proportion of subjects who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria.
3 secondary outcomes
Complete response rate (CR)
Time frame: Up to 26 months
Progression free survival (PFS)
Time frame: Up to 26 months
Overall survival (OS)
Time frame: Up to 26 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 19 Feb 2025.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 2
Elranatamab With Mezigdomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
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Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma
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Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
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Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)
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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.
Zhijuan Lin principal investigator
The First Aiffiliated hosptical of xiamen University
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 All-trans Retinoic Acid in combination with the KPD Regimen in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by The First Affiliated Hospital of Xiamen University 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 6 inclusion and 17 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 19 Feb 2025. 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?
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 Zhijuan Lin, PhD (+8615960283462, zjuan_lin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: Up to 26 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 19 Feb 2025.