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Corticosteroid
Marizomib + Dexamethasone + Pomalidomide for Multiple Myeloma
Phase 2
Waitlist Available
Led By Clifton Mo, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients in the RRMM cohort must have measurable disease defined as at least one of the following: Serum M protein ≥ 0.5 g/dL (≥5 g/L), Urine M protein ≥200 mg/24 hours, Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment until date of death from any cause, up to 5 years
Awards & highlights
Study Summary
This trial is testing whether an experimental drug is safe and effective when used with other drugs to treat cancer of the plasma cells.
Who is the study for?
This trial is for adults with multiple myeloma involving the central nervous system who've had prior treatments including an IMiD and a proteasome inhibitor. They must not be pregnant, agree to follow specific safety programs, have measurable disease levels, and can't have severe heart conditions or active infections. People with recent major surgeries or those on certain drugs are excluded.Check my eligibility
What is being tested?
The study tests marizomib's safety and effectiveness combined with standard care drugs dexamethasone and pomalidomide in treating multiple myeloma. Participants will receive these medications to see if this combination helps control their cancer better than current treatments.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, nerve damage (neuropathy), blood clots, increased risk of infection due to low blood cell counts, allergic reactions to the medication components, liver issues like hepatitis B reactivation, and other organ-related inflammations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma shows up on tests.
Select...
I have been diagnosed with multiple myeloma and need treatment now.
Select...
My multiple myeloma has spread to my brain or spinal cord.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of enrollment until date of death from any cause, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment until date of death from any cause, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD) Safety Run-In
Overall response rate (ORR)
+1 moreSecondary outcome measures
Duration of response (DOR)
Overall survival (OS)
Progression free survival (PFS)
+1 moreSide effects data
From 2023 Phase 3 trial • 749 Patients • NCT0334509567%
Nausea
62%
Fatigue
53%
Headache
52%
Vomiting
41%
Constipation
38%
Hallucination
29%
Insomnia
24%
Gait Disturbance
24%
Alopecia
23%
Dizziness
23%
Ataxia
21%
Decreased Appetite
20%
Confusional State
16%
Weight Decreased
16%
Aphasia
15%
Diarrhoea
15%
Dysarthria
14%
Balance Disorder
11%
Asthenia
11%
Fall
11%
Pyrexia
11%
Anxiety
11%
Seizure
10%
Cough
10%
Muscular Weakness
9%
Thrombocytopenia
8%
Vertigo
8%
Platelet Count Decreased
8%
Hemiparesis
7%
Hallucination, Visual
7%
Diplopia
6%
Arthralgia
6%
Somnolence
6%
Memory Impairment
6%
Oedema Peripheral
6%
Tremor
6%
Pruritus
6%
Vision Blurred
6%
Cognitive Disorder
6%
Disturbance In Attention
6%
Depression
6%
Rash
6%
Back Pain
6%
Agitation
6%
Lymphopenia
6%
Radiation Skin Injury
6%
Alanine Aminotransferase Increased
5%
Nightmare
5%
Hypertension
5%
Dysgeusia
5%
Lymphocyte Count Decreased
5%
Brain Oedema
5%
Anaemia
5%
Dyspepsia
4%
Neutropenia
4%
Urinary Tract Infection
4%
Abdominal Pain Upper
4%
Influenza Like Illness
4%
Dry Mouth
4%
Delirium
4%
Paraesthesia
4%
Tinnitus
4%
Neck Pain
4%
Injection Site Pain
4%
Neutrophil Count Decreased
4%
Hyperglycaemia
4%
Infusion Related Reaction
4%
Weight Increased
4%
Myalgia
3%
Blood Creatinine Increased
3%
Hypoaesthesia
3%
Lacrimation Increased
3%
Gamma-Glutamyltransferase Increased
3%
Urinary Incontinence
3%
Infusion Site Pain
3%
Dyspnoea
3%
Dysphonia
3%
Sleep Disorder
3%
Hypersomnia
3%
Deep Vein Thrombosis
3%
Herpes Zoster
3%
Lethargy
3%
Dermatitis
3%
Dry Skin
3%
Injection Site Reaction
3%
Amnesia
3%
Leukopenia
3%
Malignant Neoplasm Progression
3%
Abdominal Pain
3%
Face Oedema
3%
Bronchitis
3%
Aspartate Aminotransferase Increased
3%
Dehydration
3%
Speech Disorder
3%
Erythema
2%
Pneumonia
2%
Dysphagia
2%
Oropharyngeal Pain
2%
Oral Candidiasis
2%
Malaise
2%
Nasopharyngitis
2%
White Blood Cell Count Decreased
2%
Irritability
2%
Muscle Spasms
2%
Hot Flush
2%
Photopsia
2%
General Physical Health Deterioration
2%
Motor Dysfunction
2%
Thrombophlebitis Superficial
2%
Pain In Jaw
2%
Abnormal Dreams
2%
Palpitations
2%
Thrombophlebitis
2%
Hypoacusis
2%
Cushingoid
2%
Hypotension
2%
Gastrooesophageal Reflux Disease
2%
Chills
2%
Pain
2%
Depressed Mood
2%
Photophobia
2%
Hypokalaemia
2%
Pain In Extremity
2%
Rash Maculo-Papular
2%
Personality Change
2%
Epilepsy
2%
Candida Infection
2%
Neurological Decompensation
2%
Nystagmus
2%
Phlebitis
2%
Depressed Level Of Consciousness
2%
Nervous System Disorder
2%
Upper Respiratory Tract Infection
2%
Visual Impairment
2%
Blood Bilirubin Increased
2%
Ear Pain
2%
Pulmonary Embolism
1%
Neuralgia
1%
Dyspraxia
1%
Anosmia
1%
Slow Speech
1%
Lumbar Vertebral Fracture
1%
Cystitis
1%
Eye Irritation
1%
Toothache
1%
Catheter Site Thrombosis
1%
Ear Discomfort
1%
Folliculitis
1%
Infection
1%
Oral Fungal Infection
1%
Coordination Abnormal
1%
Hypophosphataemia
1%
Joint Swelling
1%
Nervousness
1%
Gastroenteritis
1%
Oral Herpes
1%
Haematuria
1%
Nasal Congestion
1%
Visual Field Defect
1%
Dysaesthesia
1%
Psychomotor Hyperactivity
1%
Bradyphrenia
1%
Delusion
1%
Vasogenic Cerebral Oedema
1%
Paranoia
1%
Pneumothorax
1%
Pancytopenia
1%
Abdominal Distension
1%
Gastritis
1%
Rectal Haemorrhage
1%
Peripheral Swelling
1%
Device Related Infection
1%
Contusion
1%
Radiation Necrosis
1%
Blood Potassium Decreased
1%
Hydrocephalus
1%
Presyncope
1%
Pollakiuria
1%
Proteinuria
1%
Embolism
1%
Tachycardia
1%
Dry Eye
1%
Vascular Pain
1%
Skin Toxicity
1%
Rhinitis
1%
Hypomagnesaemia
1%
Mucosal Inflammation
1%
Sepsis
1%
Flatulence
1%
Injection Site Bruising
1%
Facial Asymmetry
1%
Monoparesis
1%
Cerebral Haemorrhage
1%
Encephalopathy
1%
Hiccups
1%
Haematoma
1%
Haematemesis
1%
Haemorrhoids
1%
Sinus Tachycardia
1%
Glioblastoma
1%
Disorientation
1%
Rhinorrhoea
1%
Dermatitis Acneiform
1%
Perseveration
1%
Generalised Tonic-Clonic Seizure
1%
Productive Cough
1%
Eye Pain
1%
Sinusitis
1%
Catheter Site Pain
1%
Respiratory Tract Infection
1%
Transaminases Increased
1%
Vitamin B12 Deficiency
1%
Syncope
1%
Taste Disorder
1%
Micturition Urgency
1%
Gingival Bleeding
1%
Hypoaesthesia Oral
1%
Feeling Cold
1%
Oedema
1%
Peripheral Sensory Neuropathy
1%
Akathisia
1%
Mouth Ulceration
1%
Infusion Site Phlebitis
1%
Procedural Pain
1%
Hyperkalaemia
1%
Gastroenteritis Viral
1%
Blood Lactate Dehydrogenase Increased
1%
C-Reactive Protein Increased
1%
Vestibular Disorder
1%
Intracranial Pressure Increased
1%
Stomatitis
1%
Chest Pain
1%
Pharyngitis
1%
Myopathy
1%
Lower Respiratory Tract Infection
1%
Head Injury
1%
White Blood Cell Count Increased
1%
Blood Alkaline Phosphatase Increased
1%
Hyponatraemia
1%
Facial Paralysis
1%
Neuropathy Peripheral
1%
Muscle Twitching
1%
Musculoskeletal Chest Pain
1%
Partial Seizures
1%
Affect Lability
1%
Post Herpetic Neuralgia
1%
Restless Legs Syndrome
1%
Renal Failure
1%
Psychomotor Retardation
1%
Hallucination, Auditory
1%
Epistaxis
1%
Hallucinations, Mixed
1%
Mania
1%
Eczema
1%
Scar Pain
1%
Skin Irritation
1%
Urticaria
1%
Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental Arm
Standard Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Marizomib plus pomalidomide and dexamethasoneExperimental Treatment3 Interventions
A safety run-in using a modified 3+3 dose de-escalation design with relapsed/refractory multiple myeloma (RRMM) cohort, expanded to a total of 16 participants once recommended phase 2 does (RP2D) has been identified.
Marizomib (MRZ) at a pre-determined dose on Days 1, 8, 15, 22 of a 28 day study cycle
Pomalidomide (POM) at a daily predetermined dose on Days 1-21 of a 28 day study cycle
Dexamethasone (DEX) at a daily predetermined dose on Days 1, 2, 8, 9, 15, 16, 22, 23 of a 28 day study cycle
Simultaneously, relapsed/refractory multiple myeloma (RRMM) with central nervous system (CNS) involvement cohort will receive an identical modified 3+3 dose de-escalation design and expanded to an efficacy-evaluable total of 30 patients once recommended phase 2 does (RP2D has been identified
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Marizomib
2018
Completed Phase 3
~750
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
341,203 Total Patients Enrolled
51 Trials studying Multiple Myeloma
34,292 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,645 Previous Clinical Trials
4,130,969 Total Patients Enrolled
88 Trials studying Multiple Myeloma
30,508 Patients Enrolled for Multiple Myeloma
Clifton Mo, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have amyloidosis or plasma cell leukemia.I have an active hepatitis B infection.I have heart problems that are not well-managed.I can take daily aspirin, or an alternative if allergic.I developed a peeling rash from thalidomide or similar drugs.I haven't had major surgery or radiation therapy in the last 4 weeks.I had a stem cell transplant and am experiencing significant symptoms from graft-versus-host disease.My multiple myeloma shows up on tests.I have not had certain treatments within a specific time before starting this therapy.I have no lasting side effects from past treatments above mild.I haven't taken strong medication or St. John's wort in the last 14 days.I have severe nerve pain or numbness.I have CNS involvement and my condition worsened after treatment with an IMiD and a proteasome inhibitor.I take more than 10 mg/day of corticosteroids, not including inhalers, for my multiple myeloma.You have had a serious skin reaction or severe allergic reaction to IMiD's® in the past.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have been diagnosed with multiple myeloma and need treatment now.My multiple myeloma has spread to my brain or spinal cord.I have a GI condition or had a procedure that affects my ability to absorb pills.I am following the POMALYST REMS® program's testing schedule.I have HIV or active hepatitis C.I have been diagnosed with POEMS syndrome.I have not needed treatment for an infection in the last 7 days.I cannot tolerate blood clot prevention treatments.I have been treated with marizomib and did not respond to pomalidomide or its combinations.I haven't had or been treated for another cancer in the last 3 years.You are allergic to thalidomide, lenalidomide, or any other drugs used in this study.I have RRMM, treated with at least two therapies including lenalidomide and a proteasome inhibitor, and my condition worsened within 60 days after the last treatment.Your recent lab test results need to be within certain ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Marizomib plus pomalidomide and dexamethasone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the desired outcomes of this clinical investigation?
"As per Bristol-Myers Squibb, the primary outcome of this trial will be gauged over a five year span from enrolment to either documented progression or death. This assessment is titled Maximum Tolerated Dose (MTD) Safety Run-In and secondary outcomes such as Progression Free Survival (PFS), Time To Response(TTR) and Duration Of Response (DOR) will also be evaluated using IMWG's updated response criteria developed in 2011 by Rajkumar."
Answered by AI
How many volunteers are being incorporated into this research endeavor?
"This experiment is not presently accepting patients. Originally posted on March 1st 2023, the most recent edition was made July 14th 2022. For those in search of other clinical trials, there are currently 1816 studies recruiting for multiple myeloma and 571 Marizomib experiments with open enrollment."
Answered by AI
For which medical conditions is Marizomib the preferred treatment?
"Marizomib has the potential to alleviate symptoms of ophthalmia, sympathetic eye disorders, and branch retinal vein occlusions."
Answered by AI
Are there any current opportunities for individuals to become participants in this clinical trial?
"According to the data present on clinicaltrials.gov, this trial is no longer recruiting participants as it was last edited in July of 2022 and originally posted in March of 2023. Nevertheless, there are 2387 other medical studies that are currently seeking patients for their trials."
Answered by AI
What other research has been conducted concerning Marizomib?
"Currently, there are 571 clinical trials observing the potential of Marizomib with 145 in Phase 3. Most studies for this drug occur in Mishawaka, Indiana however it is being assessed at 18,862 locations worldwide."
Answered by AI
What precautions should be taken when using Marizomib therapeutically?
"Our team has judged marizomib to possess a safety rating of 2, as the Phase 2 trial does not provide evidence for efficacy yet includes some data on its security."
Answered by AI
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