Relapsed or Refractory Multiple MyelomaPhase 2NCT07312188
A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing F182112+P and F182112+CD38 in people with Relapsed or Refractory Multiple Myeloma, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- F182112+P and F182112+CD38
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2025to 20 May 2028
- 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
- Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.
- The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.
- Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.
- Have an ECOG performance status score of 0 - 2.
- Meet at least one of the following measurable disease indicators:
- Serum M - protein ≥ 5 g/L.
- Urine M - protein ≥ 200 mg/24 h.
- Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg/L and abnormal serum free light chain ratio (< 0.26 or > 1.65).
Who cannot join
- Patients with primary light - chain amyloidosis or plasma cell leukemia .
- Patients with symptoms of central nervous system involvement of multiple myeloma.
- Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose.
- Patients with active mucosal or visceral bleeding.
- Patients who have previously received BCMA - targeted therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shaohong Yin contact
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin
About this study
Official title: A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma
This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
Read the detailed description
The study plans to enroll approximately 90 patients with relapsed or refractory multiple myeloma at around 20 study centers.
Primary objective:
The objective response rate (ORR) of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
Secondary objective:
The efficacy of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma (complete response rate [CRR], progression - free survival [PFS], overall survival [OS], duration of response [DOR], time to response [TTR], time to progression [TTP], minimal residual disease - negative rate); The incidence and grade of adverse events (AE), serious adverse events (SAE), abnormal laboratory test indicators.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- F182112+P, F182112+CD38
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F182112+PDrug
Also called F182112, Pomalidomide
F182112 + P
F182112+CD38Drug
Also called F182112, BCMA CD3, CD38 monoclonal antibody
F182112+CD38
| Study group | Role | What they receive |
|---|---|---|
| F182112 combined with different administration regimens | Experimental | F182112 combined with different administration regimens Receives: Drug: F182112+P; Drug: F182112+CD38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: up to 2 years
Secondary outcomes (5)
Progression - Free Survival（PFS）
Measured: Up to 2 years
Minimal Residual Disease - negative rate
Measured: Up to 2 years
Number of Participants With Adverse Events and Serious Adverse Events
Measured: Up to 2 years
Overall Survival（OS）
Measured: Up to 2 years
Duration of Response（DOR）
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start2 Jul 2025
- Primary completion20 May 2028 (estimated)
- Study completion20 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312188
- Sponsor's protocol ID
- NTP-F182112-101
- Status last verified
- Dec 2025
- First submitted
- 24 Apr 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07312188
- Acronym / sponsor ID
- NTP-F182112-101
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 20 May 2028 (estimated)
- Study completion
- 20 May 2028 (estimated)
- First posted
- 31 Dec 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 is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
Detailed description
The study plans to enroll approximately 90 patients with relapsed or refractory multiple myeloma at around 20 study centers.
Primary objective:
The objective response rate (ORR) of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
Secondary objective:
The efficacy of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma (complete response rate [CRR], progression - free survival [PFS], overall survival [OS], duration of response [DOR], time to response [TTR], time to progression [TTP], minimal residual disease - negative rate); The incidence and grade of adverse events (AE), serious adverse events (SAE), abnormal laboratory test indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F182112 combined with different administration regimens | Experimental | Drug: F182112+P, Drug: F182112+CD38F182112 combined with different administration regimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.
- The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.
- Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.
- Have an ECOG performance status score of 0 - 2.
- Meet at least one of the following measurable disease indicators:
Key exclusion criteria (5 listed)
- Patients with primary light - chain amyloidosis or plasma cell leukemia .
- Patients with symptoms of central nervous system involvement of multiple myeloma.
- Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose.
- Patients with active mucosal or visceral bleeding.
- Patients who have previously received BCMA - targeted therapy.
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 |
|---|---|---|
| F182112+PAlso: F182112, PomalidomideF182112 + P | Drug | F182112 combined with different administration regimens |
| F182112+CD38Also: F182112, BCMA CD3, CD38 monoclonal antibodyF182112+CD38 | Drug | F182112 combined with different administration regimens |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
5 secondary outcomes
Progression - Free Survival（PFS）
Time frame: Up to 2 years
Minimal Residual Disease - negative rate
Time frame: Up to 2 years
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to 2 years
Overall Survival（OS）
Time frame: Up to 2 years
Duration of Response（DOR）
Time frame: up to 2 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 31 Dec 2025.
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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.
Shaohong Yin contact
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 F182112+P and F182112+CD38 in people with Relapsed or Refractory Multiple Myeloma, run by Shandong New Time Pharmaceutical Co., LTD 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 8 inclusion and 5 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 31 Dec 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 Lu gui Qiu Doctor (（+86）13821266636, Qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 2 years). 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 31 Dec 2025.