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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 • NCT0334509557%
Fatigue
41%
Nausea
33%
Constipation
33%
Alopecia
31%
Headache
18%
Vomiting
18%
Decreased Appetite
13%
Seizure
12%
Platelet Count Decreased
12%
Insomnia
10%
Radiation Skin Injury
10%
Thrombocytopenia
10%
Diarrhoea
10%
Dizziness
9%
Dysgeusia
9%
Asthenia
8%
Weight Decreased
8%
Confusional State
7%
Muscular Weakness
7%
Aphasia
6%
Anxiety
6%
Lymphopenia
6%
Hemiparesis
6%
Memory Impairment
6%
Anaemia
6%
Lymphocyte Count Decreased
5%
Depression
5%
Gait Disturbance
5%
Dyspnoea
5%
Fall
5%
Neutrophil Count Decreased
5%
Cough
4%
Dysarthria
4%
Vision Blurred
4%
Pruritus
4%
White Blood Cell Count Decreased
4%
Tremor
4%
General Physical Health Deterioration
4%
Pyrexia
4%
Back Pain
4%
Brain Oedema
4%
Cognitive Disorder
4%
Alanine Aminotransferase Increased
4%
Neutropenia
4%
Weight Increased
3%
Urinary Tract Infection
3%
Hypertension
3%
Arthralgia
3%
Balance Disorder
3%
Dyspepsia
3%
Oedema Peripheral
3%
Myalgia
3%
Dermatitis
3%
Dry Skin
2%
Face Oedema
2%
Upper Respiratory Tract Infection
2%
Abdominal Pain
2%
Partial Seizures
2%
Malignant Neoplasm Progression
2%
Paraesthesia
2%
Disturbance In Attention
2%
Erythema
2%
Leukopenia
2%
Gastrooesophageal Reflux Disease
2%
Influenza Like Illness
2%
Epilepsy
2%
Syncope
2%
Pain In Extremity
2%
Cushingoid
2%
Oral Candidiasis
2%
Apraxia
2%
Herpes Zoster
2%
Hypokalaemia
2%
Malaise
2%
Blood Creatinine Increased
2%
Tinnitus
2%
Abdominal Pain Upper
2%
Hyperglycaemia
2%
Hypoaesthesia
1%
Palpitations
1%
Delirium
1%
Thrombosis
1%
Scar Pain
1%
Diplopia
1%
Musculoskeletal Pain
1%
Dermatitis Allergic
1%
Candida Infection
1%
Aspartate Aminotransferase Increased
1%
Herpes Simplex Reactivation
1%
Ocular Hyperaemia
1%
Irritability
1%
Petechiae
1%
Hydrocephalus
1%
Toothache
1%
Gastroenteritis
1%
Contusion
1%
Dyskinesia
1%
Nephrolithiasis
1%
Eye Pain
1%
Flank Pain
1%
Osteoarthritis
1%
Haematuria
1%
Pollakiuria
1%
Polyuria
1%
Pain Of Skin
1%
Dysphagia
1%
Oropharyngeal Pain
1%
Cataract
1%
Haemorrhoids
1%
Motor Dysfunction
1%
Pneumonitis
1%
Scar Inflammation
1%
Flatulence
1%
Gastrointestinal Pain
1%
Myopathy
1%
Gamma-Glutamyltransferase Increased
1%
Amnesia
1%
Bradyphrenia
1%
Haematoma
1%
Vasogenic Cerebral Oedema
1%
Dry Mouth
1%
Discomfort
1%
Influenza
1%
Skin Laceration
1%
Restlessness
1%
Somnolence
1%
Nasopharyngitis
1%
Stomatitis
1%
Rash
1%
Cellulitis
1%
Lacrimation Increased
1%
Hypomagnesaemia
1%
Blood Cholesterol Increased
1%
Pulmonary Embolism
1%
Sinus Tachycardia
1%
Photophobia
1%
Vitreous Floaters
1%
Gingival Pain
1%
Chills
1%
Anosmia
1%
Epistaxis
1%
Taste Disorder
1%
Hot Flush
1%
Glucose Tolerance Impaired
1%
Complex Regional Pain Syndrome
1%
Neurological Decompensation
1%
Generalised Tonic-Clonic Seizure
1%
Peripheral Sensory Neuropathy
1%
Dermatitis Contact
1%
Odynophagia
1%
Intracranial Pressure Increased
1%
Oedema
1%
Dysphonia
1%
Acne
1%
Conjunctivitis Viral
1%
Deep Vein Thrombosis
1%
Radiation Alopecia
1%
Pain
1%
Cystitis
1%
Depressed Level Of Consciousness
1%
Sinus Congestion
1%
Conjunctivitis
1%
Facial Paresis
1%
Urinary Incontinence
1%
Bronchitis
1%
Oral Herpes
1%
Pneumonia
1%
Ear Pain
1%
Deafness
1%
Visual Impairment
1%
Abdominal Distension
1%
Vertigo
1%
Fungal Infection
1%
Speech Disorder
1%
Muscle Spasms
1%
Ataxia
1%
Lethargy
1%
Dizziness Postural
1%
Hemianopia
1%
Nervous System Disorder
1%
Abulia
1%
Nocturia
1%
Disorientation
1%
Agitation
1%
Nasal Congestion
1%
Psoriasis
1%
Dermatitis Acneiform
1%
Rash Maculo-Papular
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Arm
Experimental 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
340,900 Total Patients Enrolled
51 Trials studying Multiple Myeloma
34,292 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,802 Total Patients Enrolled
88 Trials studying Multiple Myeloma
30,503 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.
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