Relapsed or Refractory Multiple MyelomaPhase 1/2NCT05647512
Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases
A Phase 1/2 study testing LM-305 and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma and Other Plasma Cell Diseases, run by LaNova Medicines Limited.
Trial summary
A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma, Other Plasma Cell Diseases
- What is being tested?
- LM-305 and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2023to 30 Dec 2025
- Phase
- Phase 1/2
- 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
- Subjects will be enrolled into the study only if they meet all of the following inclusion criteria:
- Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Aged ≥18 years old when sign the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。
- Life expectancy ≥ 6 months.
- Subjects must show appropriate organ and marrow function in laboratory examinations
Who cannot join
- Subjects will be excluded from the study, if they meet any of the following criteria:
- A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing
- Subjects who have severe cardiovascular disease。
- Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP.
- Child-bearing potential female who have positive results in pregnancy test or are lactating.
- Subject who is judged as not eligible to participate in this study by the investigator.
About this study
Official title: A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases
A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Read the detailed description
A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
- Being tested
- LM-305, Dexamethasone
- 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.
LM-305Drug
Administered intravenously
DexamethasoneDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LM-305 Dose Escalation | Experimental | Administered intravenously Receives: Drug: LM-305 |
| LM-305 Combination Expansion | Experimental | LM-305 Administered intravenously Dexamethasone Orally Receives: Drug: LM-305; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period
Measured: Cycle 1 of each cohort. Duration of one cycle is 21 days
Adverse Events (AE) and Serious Adverse Events (SAE)
The safety profile of LM-305 will be assessed by monitoring the adverse events
Measured: From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy
Secondary outcomes (1)
Area under plasma concentration vs time curve (AUC) for LM-305
changes in AUC over time in participants with LM-305
Measured: Up to finished cycle 5 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start18 Jan 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: According to sponsor strategy
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 LaNova Medicines LimitedThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Depei Wu, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647512
- Sponsor's protocol ID
- LM305-01-102
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2022
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases
- ClinicalTrials.gov ID
- NCT05647512
- Acronym / sponsor ID
- LM305-01-102
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: According to sponsor strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Dec 2022 (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.
A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Detailed description
A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LM-305 Dose Escalation | Experimental | Drug: LM-305Administered intravenously |
| LM-305 Combination Expansion | Experimental | Drug: LM-305, Drug: DexamethasoneLM-305 Administered intravenously Dexamethasone Orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects will be enrolled into the study only if they meet all of the following inclusion criteria:
- Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Aged ≥18 years old when sign the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。
- Life expectancy ≥ 6 months.
Key exclusion criteria (6 listed)
- A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing
- Subjects who have severe cardiovascular disease。
- Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP.
- Child-bearing potential female who have positive results in pregnancy test or are lactating.
- Subject who is judged as not eligible to participate in this study by the investigator.
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 |
|---|---|---|
| LM-305Administered intravenously | Drug | LM-305 Combination Expansion, LM-305 Dose Escalation |
| DexamethasoneAdministered orally | Drug | LM-305 Combination Expansion |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Cycle 1 of each cohort. Duration of one cycle is 21 days
DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period
Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy
The safety profile of LM-305 will be assessed by monitoring the adverse events
1 secondary outcome
Area under plasma concentration vs time curve (AUC) for LM-305
Time frame: Up to finished cycle 5 (each cycle is 21 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Related trials for Relapsed or Refractory Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
Active, not recruitingPhase 3
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
RecruitingPhase 2
Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma
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.
Depei Wu principal investigator
The First Affiliated Hospital of Soochow University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LM-305 and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma and Other Plasma Cell Diseases, run by LaNova Medicines Limited.
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 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: withdrawn, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Cycle 1 of each cohort. Duration of one cycle is 21 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 18 Nov 2023.