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NMS-03597812 + Dexamethasone for Multiple Myeloma
Phase 1
Recruiting
Research Sponsored by Nerviano Medical Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start date until disease progression or relapse (up to approximately 12 months).
Awards & highlights
Study Summary
This trial is testing a new drug for people with a certain type of cancer who have exhausted other treatment options. The goal is to see if the drug is safe and effective.
Who is the study for?
Adults over 18 with relapsed or refractory multiple myeloma, who've tried at least three prior treatments including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody. They must have measurable disease and be able to swallow capsules. Excluded are those with certain heart conditions, recent major surgery, active infections like HIV/HBV/HCV, uncontrolled diabetes or other serious medical issues.Check my eligibility
What is being tested?
The trial is testing NMS-03597812 alone or combined with dexamethasone in patients whose multiple myeloma has not responded to standard treatments. It's an early-phase study focusing on safety and how the body processes the drugs.See study design
What are the potential side effects?
Potential side effects of NMS-03597812 may include typical drug reactions such as nausea, fatigue, allergic responses and possibly blood-related issues due to its nature as a cancer treatment. Dexamethasone can cause increased appetite, mood changes, insomnia and raise blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children and have a negative pregnancy test before starting the study drug.
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All side effects from my previous treatments, except for hair loss, are mild or gone.
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I can swallow pills without breaking them.
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I've had 3 types of treatments for my condition, including proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.
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My condition worsened despite the last treatment.
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I can care for myself but may not be able to do active work.
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My multiple myeloma has come back or is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from treatment start date until disease progression or relapse (up to approximately 12 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start date until disease progression or relapse (up to approximately 12 months).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with first-cycle dose limiting toxicity
Secondary outcome measures
Accumulation ratio (Rac) of NMS-03597812 after multiple doses of drug
Apparent volume of distribution (Vd/F) of NMS-03597812 after multiple doses of drug
Area under the plasma concentration versus time curve to infinity (AUCinf) of NMS-03597812 after multiple doses of drug
+16 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Dose Expansion Part - NMS-03597812 single agentExperimental Treatment1 Intervention
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
Group II: Dose Expansion Part - NMS-03597812 in combination with dexamethasoneExperimental Treatment1 Intervention
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
Group III: Dose Escalation PartExperimental Treatment1 Intervention
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
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Who is running the clinical trial?
Nerviano Medical SciencesLead Sponsor
12 Previous Clinical Trials
875 Total Patients Enrolled
1 Trials studying Multiple Myeloma
7 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication that cannot be replaced and is sensitive to certain enzymes.I do not have any uncontrolled infections and am not HIV, HBV, or HCV positive.I haven't taken cancer drugs in the last 3 weeks, or immunotherapy in the last 6 weeks.I had a stem cell transplant using my own cells less than 3 months ago.I have not had major surgery in the last 4 weeks.I have had significant bleeding inside my body.I am a woman who can have children and have a negative pregnancy test before starting the study drug.You are allergic to any of the ingredients in the NMS-03597812 drug.I had GVHD but stopped immunosuppressive treatment over 3 months ago.All side effects from my previous treatments, except for hair loss, are mild or gone.I do not have active gastrointestinal diseases that affect drug absorption.I can swallow pills without breaking them.I do not have a long QT interval or risk factors for severe heart rhythm problems.I have not had a heart attack, severe heart failure, stroke, or blood clots in the last 6 months.I have been diagnosed with POEMS syndrome.I have another cancer, but it's only skin cancer, cervical cancer treated with a cone biopsy, or superficial bladder cancer.I've had 3 types of treatments for my condition, including proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.I have tried all treatments for my condition without success or cannot tolerate them.You must have a certain amount of abnormal protein in your blood or urine for the study.My multiple myeloma has spread to my brain or spinal cord.My body does not respond to platelet transfusions.My blood, kidney, liver, and pancreas tests are within normal ranges.I have had pancreatitis or currently abuse alcohol.My condition worsened despite the last treatment.I am 18 years old or older.My diabetes is not under control.I have not had CAR-T cell therapy within the last 3 months.My multiple myeloma has not responded to any treatment.My condition is non-secretory myeloma.I have been diagnosed with plasma cell leukemia, Waldenstrom's macroglobulinemia, or amyloidosis.I am taking medication that strongly affects certain liver enzymes and cannot switch to another.I am willing and able to follow the study's schedule and procedures.I can care for myself but may not be able to do active work.I had a stem cell transplant less than 6 months ago.I am taking more than 10 mg/day of prednisone or its equivalent, and my dose has been stable for at least a week.I haven't had radiotherapy in the last 3 weeks, or if I did, it affected less than 5% of my bone marrow.I am not allergic to steroids or dexamethasone.My multiple myeloma has come back or is not responding to treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What symptoms can NMS-03597812 ameliorate?
"NMS-03597812 is a frequently used drug for the management of ophthalmia, sympathetic. It has also been observed to effectively treat eye diseases like branch retinal vein occlusion and macular edema."
Answered by AI
Can one assume a degree of safety when taking NMS-03597812?
"As NMS-03597812 is a Phase 1 trial, our team at Power scores the potential safety of this medication as a 1 due to limited clinical evidence supporting its efficacy and protective measures."
Answered by AI
Has this research still vacancies for participants?
"Affirmative. Clinicaltrials.gov shows that this research, which went public on September 9th 2022 and was last revised on November 18th 2022, is currently seeking recruits. 65 people are required from four distinct locations for the trial to be successful."
Answered by AI
How extensive is the geographic coverage of this research in city?
"The number of medical establishments involved in this investigation includes the Dana-Farber Cancer Institute, located in Boston; Memorial Sloan Kettering's Cancer Center, based in New york City; and Levine Cancer Institute situated within Charlotte. Additionally, there is a fourth site that has yet to be disclosed."
Answered by AI
Are there any prior scientific researches related to NMS-03597812?
"Presently, 552 clinical trials are running in regards to NMS-03597812 with 144 of them being Phase 3 studies. Many of these investigations have taken place in Joliet, Illinois but there are 18606 locations where research into this treatment is occurring."
Answered by AI
How many participants are engaging in this clinical investigation?
"In order to carry out the trial, Nerviano Medical Sciences is seeking 65 qualified participants. The research will be conducted at Dana- Farber Cancer Institute in Boston and Memorial Sloan Kettering Cancer Center in New york City."
Answered by AI
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