Multiple MyelomaPhase 1NCT05027594
Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing NMS-03597812 and NMS-03597812 + dexamethasone in people with Multiple Myeloma, run by Nerviano Medical Sciences at 2 sites in United States.
Trial summary
This is a Phase I, first-in-human (FIH), open-label, non-randomized, multi-center study to explore the safety, tolerability, pharmacokinetics and preliminary antitumor activity of NMS-03597812 in adult patients with RRMM who have exhausted standard treatment options that are expected to provide meaningful clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- NMS-03597812 and NMS-03597812 + dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2022to 8 Jan 2024
- Phase
- Phase 1
- 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
- Patients must have a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria)
- Patients must have exhausted available therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance or refusal of the therapy.
- Patients must have received at least three prior lines of therapy as defined by IMWG, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
- Patients must have progressive/refractory disease to the last line of therapy.
- Patients must have measurable disease, defined as any of the following:serum monoclonal protein ≥ 0.5 g/dL by protein electrophoresis, ≥200 mg of monoclonal protein in urine on 24-h electrophoresis, or serum immunoglobulin free light chain ≥10 mg/dL with abnormal free-light-chain ratio.
- Adult (age ≥18 years) patients.
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- Karnofsky performance status ≥60%.
- All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTCAE version 5.0 Grade ≤1 or according to inclusion criterion 9.
- Adequate hematological profile, renal, hepatic and pancreatic functions
- All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the screening period prior to start of the study drug.
- Patients must use effective contraception or abstinence. Female patients of childbearing potential must agree to use effective contraception or abstinence during the period of therapy and in the following 90 days after discontinuation of study treatment. Male patients must be surgically sterile or must agree to use effective contraception or abstinence during the period of therapy and in the following 90 days after discontinuation of study treatment.
- Ability to swallow capsules intact (without chewing, crushing, or opening).
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study indications or procedures.
- Signed and dated IRB/EC-approved Informed Consent
Who cannot join
- Current enrollment in another interventional clinical study.
- Diagnosis of primary refractory multiple myeloma defined as disease that is non-responsive in patients who have never achieved a minimal response or better with any therapy
- Diagnosis of plasma cell leukemia, Waldenstrom's macroglobulinemia or amyloidosis.
- Diagnosis of non-secretory myeloma.
- Known central nervous system (CNS) involvement by multiple myeloma.
- Known history of polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
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- Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and/or conebiopsied in situ carcinoma of the cervix uteri and/or superficial bladder cancer.
- Autologous stem cell transplant ≤3 months prior to starting NMS-03597812.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤6 months prior to starting NMS-03597812.
- Active acute or chronic graft versus host disease (GVHD) requiring immunosuppressive treatment. Patients who experienced GVHD requiring immunosuppressive treatment, must have stopped immunosuppressive treatment >3 months prior to starting NMS-03597812.
- Any anticancer agent within 3 weeks (6 weeks for immunotherapy or nitrosoureas).
- Prior CAR-T cell <3 months prior to starting NMS-03597812.
- Concomitant oral prednisone(or equivalent)>10 mg/day. Doses of corticosteroid must have been stable for at least 7 days before startingNMS-03597812.
- Major surgery within 4 weeks before treatment start.
- Radiotherapy within 3 weeks prior to starting NMS-03597812. However, if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy.
- Patient with evidence of clinically significant mucosal or internal bleeding.
- Patient platelet transfusion refractory.
- History of pancreatitis or current alcohol abuse.
- Uncontrolled diabetes.
- Patients with QTc interval ≥ 480 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc interval or family history of long QT syndrome). For patients receiving treatment with concomitant medications known to prolong the QTc interval, replacement with another treatment should be considered. If replacement or discontinuation is not clinically feasible, a careful risk/benefit evaluation should be performed prior to enrollment.
- Breast-feeding or planning to breast feed during the study or within 3 months after study treatment.
- Known hypersensitivity to any of the components of the NMS-03597812 drug product.
- Known hypersensitivity to steroids or any of the components of the dexamethasone drug product (applies only to the expansion cohort testing NMS-03597812 in combination with dexamethasone).
- Any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Uncontrolled bacterial, viral, or fungal infections including: known infection with HIV, HBV and/or HCV; patients who are seropositive following HBV vaccine are eligible.
- Known active gastrointestinal disease (e.g., documented gastrointestinal ulcer, Crohn's disease, ulcerative colitis or short gut syndrome) or other malabsorption syndromes that would impact drug absorption or represent a contra-indication for the treatment with dexamethasone (NMS-03597812 and dexamethasone expansion cohort).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- Patient who are receiving concomitant medications that are strong inducers or inhibitors of CYP34A and CYP2C9 that cannot be replaced with alternative therapy.
- Patients who are receiving concomitant medications that are sensitive substrates of CYP3A4 and CYP2D6 with narrow therapeutic window that cannot be replaced with alternative therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana- Farber Cancer Institute
Boston, Massachusetts, 02215-5450
Levine Cancer Institute
Charlotte, North Carolina, 28204-2839
About this study
Official title: A Phase I Dose Escalation Study of NMS-03597812, a PERK Inhibitor, in Adult Patients With Relapsed or Refractory Multiple Myeloma
This is a Phase I, first-in-human (FIH), open-label, non-randomized, multi-center study to explore the safety, tolerability, pharmacokinetics and preliminary antitumor activity of NMS-03597812 in adult patients with RRMM who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable.
- Conditions
- Multiple Myeloma
- Being tested
- NMS-03597812, NMS-03597812 + dexamethasone
- Keywords
- Phase I, Multiple Myeloma, PERK inhibitor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMS-03597812Drug
All patients will receive NMS-03597812 administered orally once daily on Days 1-21 in repeated 4-week cycles.
NMS-03597812 + dexamethasoneDrug
All patients will receive NMS-03597812 administered orally once daily on Days 1-21 and Dexamethasone administered orally once a week on Days 1, 8, 15 and 22 in repeated 4-week cycles.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Part | Experimental | Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable Receives: Drug: NMS-03597812 |
| Dose Expansion Part - NMS-03597812 single agent | Experimental | Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable Receives: Drug: NMS-03597812 |
| Dose Expansion Part - NMS-03597812 in combination with dexamethasone | Experimental | Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable Receives: Drug: NMS-03597812 + dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with first-cycle dose limiting toxicity
For DLT evaluation, severity (grade) is classified according to common terminology criteria for adverse events version 5.0 (CTCAE v5.0).
Measured: Time interval between the date of the first dose administration in Cycle 1 (each cycle is 28 days) and the date of the first dose administration in Cycle 2 which is expected to be 28 days or up to 42 days in case of dose delay due to toxicity
Secondary outcomes (19)
Number of participants with Adverse Events (AEs)
Safety will be assessed by adverse events (AEs), which include clinically significant abnormalities identified during a medical test (e.g. laboratory tests, electrocardiogram, vital signs, physical examinations). AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) and their severity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). The analysis will focus on the events reported after the start of treatment (treatment emergent adverse events).
Measured: From the Informed Consent signature to 28 days after the last dose of study treatment administration
Number of Participants by Best Tumor response
Number of patients with best tumor response achieved on treatment is determined using International Myeloma Working Group (IMWG) Criteria 2016. The number of patients is provided for each category: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD), Progressive Disease (PD) and Not Evaluable (NE).
Measured: From treatment start date until disease progression or relapse (up to approximately 12 months).
Number of Participants with Overall Response
Best Overall Response is measured for patients achieving Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as Best Response according to International Myeloma Working Group (IMWG) Criteria 2016
Measured: From treatment start date until disease progression or relapse (up to approximately 12 months).
Number of Participants with Clinical Benefit
Clinical Benefit is measured for patients achieving Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR) or Minimal Response (MR) as Best Response according to International Myeloma Working Group (IMWG) Criteria 2016.
Measured: From treatment start date until disease progression or relapse (up to approximately 12 months).
Duration of Response
Duration of Response is calculated in patients achieving overall response by International Myeloma Working Group (IMWG) Criteria 2016, as the time elapsed from the date at which Overall response is first observed to the date of first observed disease progression/relapse or date of death due to progression, whichever comes first
Measured: From the first responding tumor assessment until Progression Disease/Relapse or Death due to Progression (up to approximately 12 months)
Progression Free Survival (PFS)
Progression Free Survival (PFS) is calculated as the time elapsed from the date of treatment initiation to the date of first documentation of disease progression/relapse according to International Myeloma Working Group (IMWG) Criteria 2016, or death due to any cause, whichever comes first
Measured: From date of first dose of study drug up to the date of first documentation of disease progression/relapse or death due to any cause, whichever comes first (up to approximately 12 months).
Maximum concentration (Cmax) of NMS-03597812 after single and multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21 at different timepoints.
Time to maximum plasma concentration (Tmax) of NMS-03597812 after single and multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Area under the plasma concentration versus time curve up to the last detectable plasma concentration (AUClast) of NMS-03597812 after single and multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Minimum plasma concentration (Cmin) of NMS-03597812 after single and multiple doses of drug.
Plasma samples will be collected and used for pharmacokinetics assessments.
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Average plasma concentration (Cave) of NMS-03597812 after multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Area under the plasma concentration versus time curve to infinity (AUCinf) of NMS-03597812 after multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and Cycle 2 on Days 1, 8, 15, 21 at different timepoints.
Terminal elimination half-life (t1/2) of NMS-03597812 after multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and Cycle 2 on Days 1, 8, 15, 21, at different timepoints
Oral plasma clearance (CL/F) of NMS-03597812 after multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Apparent volume of distribution (Vd/F) of NMS-03597812 after multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints
Accumulation ratio (Rac) of NMS-03597812 after multiple doses of drug
Plasma samples will be collected and used for pharmacokinetics assessments.
Measured: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints
Renal clearance of NMS-03597812 after multiple doses of drug.
Urine samples will be used for PK assessments. Samples will be collected in patients treated in the dose escalation phase, starting from cohort 4 or from the occurrence of the first DLT, whichever comes first, and in all patients treated in the dose expansion.
Measured: At Cycle 1 (each cycle is 28 days) Day 1 and Day 21
Cumulative amount recovered unchanged in the urine (Ae) of NMS-03597812 after multiple doses of drug
Urine samples will be used for PK assessments. Samples will be collected in patients treated in the dose escalation phase, starting from cohort 4 or from the occurrence of the first DLT, whichever comes first, and in all patients treated in the dose expansion.
Measured: At Cycle 1 (each cycle is 28 days) Day 1 and Day 21
Cumulative amount recovered unchanged in the urine expressed as a fraction of administered dose (Ae%) of NMS-03597812 after multiple doses of drug.
Urine samples will be used for PK assessments. Samples will be collected in patients treated in the dose escalation phase, starting from cohort 4 or from the occurrence of the first DLT, whichever comes first, and in all patients treated in the dose expansion.
Measured: At Cycle 1 (each cycle is 28 days) Day 1 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start9 Sep 2022
- Primary completion8 Aug 2023
- Study completion8 Jan 2024
Why it stopped: The decision is not based on emerging safety or efficacy concerns but on strategic reasons related to the changing and competitive treatment options in Multiple Myeloma
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 Dose escalation part followed by a Dose Expansion part.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerviano Medical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027594
- Sponsor's protocol ID
- PERKA-812-001
- Other IDs
- 2020-004351-32
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2021
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of NMS-03597812, a PERK Inhibitor, in Adult Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05027594
- Acronym / sponsor ID
- PERKA-812-001
- Conditions
- Multiple Myeloma
- Keywords
- Phase I, Multiple Myeloma, PERK inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision is not based on emerging safety or efficacy concerns but on strategic reasons related to the changing and competitive treatment options in Multiple Myeloma
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nerviano Medical SciencesIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 30 Aug 2021 (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 Phase I, first-in-human (FIH), open-label, non-randomized, multi-center study to explore the safety, tolerability, pharmacokinetics and preliminary antitumor activity of NMS-03597812 in adult patients with RRMM who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1 Dose escalation part followed by a Dose Expansion part.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Part | Experimental | Drug: NMS-03597812Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable |
| Dose Expansion Part - NMS-03597812 single agent | Experimental | Drug: NMS-03597812Patients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable |
| Dose Expansion Part - NMS-03597812 in combination with dexamethasone | Experimental | Drug: NMS-03597812 + dexamethasonePatients with a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria) who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have a confirmed diagnosis of relapsed or relapsed and refractory multiple myeloma (as per IMWG criteria)
- Patients must have exhausted available therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance or refusal of the therapy.
- Patients must have received at least three prior lines of therapy as defined by IMWG, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
- Patients must have progressive/refractory disease to the last line of therapy.
- Patients must have measurable disease, defined as any of the following:serum monoclonal protein ≥ 0.5 g/dL by protein electrophoresis, ≥200 mg of monoclonal protein in urine on 24-h electrophoresis, or serum immunoglobulin free light chain ≥10 mg/dL with abnormal free-light-chain ratio.
Key exclusion criteria (29 listed)
- Current enrollment in another interventional clinical study.
- Diagnosis of primary refractory multiple myeloma defined as disease that is non-responsive in patients who have never achieved a minimal response or better with any therapy
- Diagnosis of plasma cell leukemia, Waldenstrom's macroglobulinemia or amyloidosis.
- Diagnosis of non-secretory myeloma.
- Known central nervous system (CNS) involvement by multiple myeloma.
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 |
|---|---|---|
| NMS-03597812All patients will receive NMS-03597812 administered orally once daily on Days 1-21 in repeated 4-week cycles. | Drug | Dose Escalation Part, Dose Expansion Part - NMS-03597812 single agent |
| NMS-03597812 + dexamethasoneAll patients will receive NMS-03597812 administered orally once daily on Days 1-21 and Dexamethasone administered orally once a week on Days 1, 8, 15 and 22 in repeated 4-week cycles. | Drug | Dose Expansion Part - NMS-03597812 in combination with dexamethasone |
Primary outcome
Number of Participants with first-cycle dose limiting toxicity
Time frame: Time interval between the date of the first dose administration in Cycle 1 (each cycle is 28 days) and the date of the first dose administration in Cycle 2 which is expected to be 28 days or up to 42 days in case of dose delay due to toxicity
For DLT evaluation, severity (grade) is classified according to common terminology criteria for adverse events version 5.0 (CTCAE v5.0).
19 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: From the Informed Consent signature to 28 days after the last dose of study treatment administration
Number of Participants by Best Tumor response
Time frame: From treatment start date until disease progression or relapse (up to approximately 12 months).
Number of Participants with Overall Response
Time frame: From treatment start date until disease progression or relapse (up to approximately 12 months).
Number of Participants with Clinical Benefit
Time frame: From treatment start date until disease progression or relapse (up to approximately 12 months).
Duration of Response
Time frame: From the first responding tumor assessment until Progression Disease/Relapse or Death due to Progression (up to approximately 12 months)
Progression Free Survival (PFS)
Time frame: From date of first dose of study drug up to the date of first documentation of disease progression/relapse or death due to any cause, whichever comes first (up to approximately 12 months).
Maximum concentration (Cmax) of NMS-03597812 after single and multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21 at different timepoints.
Time to maximum plasma concentration (Tmax) of NMS-03597812 after single and multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Area under the plasma concentration versus time curve up to the last detectable plasma concentration (AUClast) of NMS-03597812 after single and multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Minimum plasma concentration (Cmin) of NMS-03597812 after single and multiple doses of drug.
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Average plasma concentration (Cave) of NMS-03597812 after multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Area under the plasma concentration versus time curve to infinity (AUCinf) of NMS-03597812 after multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and Cycle 2 on Days 1, 8, 15, 21 at different timepoints.
Terminal elimination half-life (t1/2) of NMS-03597812 after multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and Cycle 2 on Days 1, 8, 15, 21, at different timepoints
Oral plasma clearance (CL/F) of NMS-03597812 after multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints.
Apparent volume of distribution (Vd/F) of NMS-03597812 after multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints
Accumulation ratio (Rac) of NMS-03597812 after multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) on Days 1, 2, 8, 15, 21, 22, 23 and 24 and at Cycle 2 on Days 1, 8, 15, 21, at different timepoints
Renal clearance of NMS-03597812 after multiple doses of drug.
Time frame: At Cycle 1 (each cycle is 28 days) Day 1 and Day 21
Cumulative amount recovered unchanged in the urine (Ae) of NMS-03597812 after multiple doses of drug
Time frame: At Cycle 1 (each cycle is 28 days) Day 1 and Day 21
Cumulative amount recovered unchanged in the urine expressed as a fraction of administered dose (Ae%) of NMS-03597812 after multiple doses of drug.
Time frame: At Cycle 1 (each cycle is 28 days) Day 1 and Day 21
Results and safety
The study was stopped early (reason given: The decision is not based on emerging safety or efficacy concerns but on strategic reasons related to the changing and competitive treatment options in Multiple Myeloma). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NMS-03597812 and NMS-03597812 + dexamethasone in people with Multiple Myeloma, run by Nerviano Medical Sciences at 2 sites in United States.
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 14 inclusion and 29 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: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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.
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 stopped early (reason given: The decision is not based on emerging safety or efficacy concerns but on strategic reasons related to the changing and competitive treatment options in Multiple Myeloma). Results are not available in the source record.
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?
Number of Participants with first-cycle dose limiting toxicity (time frame: Time interval between the date of the first dose administration in Cycle 1 (each cycle is 28 days) and the date of the first dose administration in Cycle 2 which is expected to be 28 days or up to 42 days in case of dose delay due to toxicity). 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 Jun 2025.