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Monoclonal Antibodies
Immuno-Oncology Therapy for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Madhav V. Dhodapkar, M.D.
Research Sponsored by Multiple Myeloma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease of MM as defined by at least ONE of the following: Serum monoclonal protein ≥1.0 g by protein electrophoresis, ≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis, Serum immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio
Patient has received at least 3 prior lines of therapy and must have received prior therapy including at least one drug from each drug class; IMiD, proteasome inhibitors, and anti-CD38 monoclonal antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 18 months.
Awards & highlights
Study Summary
This trial is for patients with Multiple Myeloma who have relapsed after treatment with prior therapies. The protocol is designed to evaluate two agents, Anti-LAG-3 and Anti-TIGIT, in order to understand their immunologic effects and safety both as single agents and in combination with pomalidomide and dexamethasone.
Who is the study for?
Adults with relapsed refractory Multiple Myeloma who've had at least three prior treatments, including IMiDs, proteasome inhibitors, and anti-CD38 monoclonal antibodies. Participants must have normal or stable thyroid function, acceptable blood counts and organ function, no history of certain autoimmune diseases or CNS involvement, not be pregnant or breastfeeding, and agree to contraception use.Check my eligibility
What is being tested?
The trial is testing Anti-LAG-3 and Anti-TIGIT immunotherapy drugs alone and in combination with pomalidomide plus dexamethasone against the standard FDA-approved combo of elotuzumab with pomalidomide and dexamethasone. It aims to assess their safety profile and effect on the immune system in multiple myeloma treatment.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions such as inflammation in various organs, infusion-related responses like fever or chills, fatigue from treatment exhaustion, possible blood count changes leading to increased infection risk or bleeding tendencies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma shows specific protein levels in blood or urine tests.
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I've had 3 or more treatments including IMiD, proteasome inhibitors, and anti-CD38.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 18 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 18 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency, type and grade of Adverse Events and Serious Adverse Events
Overall Response Rate
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Arm C - Anti-TIGIT Single AgentExperimental Treatment1 Intervention
Patients receive Anti-TIGIT as a single agent for 1 Cycle in Phase 1 portion.
Group II: Arm B:Combination Anti LAG-3 +Pomalidomide+DexamethasoneExperimental Treatment1 Intervention
Cycle 2 and beyond Patients receive Anti-LAG-3 in combination with pomalidomide and dexamethasone.
Group III: Arm B - Anti LAG-3 Single AgentExperimental Treatment1 Intervention
Patients receive Anti-LAG-3 as a single agent for 1 Cycle in Phase 1 portion.
Group IV: ARM C: Anti-TIGIT +Pomalidomide+DexamethasoneExperimental Treatment1 Intervention
Cycle 2 and beyond Patients receive Anti-TIGIT in combination with pomalidomide and dexamethasone.
Group V: Arm A - ElotuzumabActive Control1 Intervention
Patients receive Elotuzumab in combination with pomalidomide and dexamethasone. Arm A begings in Phase 2 portion.
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthOTHER
131 Previous Clinical Trials
28,230 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,406 Patients Enrolled for Multiple Myeloma
University of MichiganOTHER
1,798 Previous Clinical Trials
6,378,124 Total Patients Enrolled
1 Trials studying Multiple Myeloma
729 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research ConsortiumLead Sponsor
20 Previous Clinical Trials
1,314 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,261 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to go back to the hospital where I enrolled for my check-ups.I haven't taken any cancer treatments or investigational drugs within the specified time frames before starting this therapy.I cannot tolerate blood clot prevention treatments.You have had a serious skin reaction or severe allergic reaction to similar medications in the past.I don't have lasting side effects from past treatments, except for hair loss or mild nerve issues without pain.Criterion: Your recent blood tests show certain levels within a specific range. For example, your white blood cell count needs to be above a certain number, and your hemoglobin and platelet levels need to be within a certain range. Your liver and kidney function also need to be within a specific range.I haven't had major surgery or radiation within the last 4 weeks.My multiple myeloma shows specific protein levels in blood or urine tests.I have previously been treated with Anti-TIGIT, Anti-LAG-3, or Elotuzumab.I have a history of specific lung conditions without a known cause.I've had 3 or more treatments including IMiD, proteasome inhibitors, and anti-CD38.I have an autoimmune disease that needs treatment.I can take daily aspirin or other blood thinners if needed.Your cardiac troponin levels are more than double the normal limit for the testing facility.I am 18 years old or older.My heart condition does not severely limit my physical activity.Women who could become pregnant must have a negative pregnancy test within a week before starting treatment, and must have another test at the beginning of each treatment cycle and at the end of treatment.I have had a stem cell transplant from a donor.I had a stem cell transplant using my own cells less than 12 weeks ago.I agree to follow the safety program for POMALYST® and use birth control as required.My heart's electrical activity is normal, except if I have a right bundle branch block.I have not needed strong infection treatment in the last week.I am able to care for myself and perform daily activities.I do not have amyloidosis, plasma cell leukemia, or POEMS syndrome.My cancer has spread to my brain or spinal cord.My thyroid function is normal or stable with medication.You have HIV, Hepatitis B, or active Hepatitis C infection.I do not have any major uncontrolled health issues like recent heart attacks or severe heart problems.I have a severe intolerance to steroids that can't be managed by lowering the dose.I have not taken immunosuppressive drugs in the last 2 months.I have been cancer-free for over 3 years, except for minor skin cancers or early-stage cervical, breast, or prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A - Elotuzumab
- Group 2: Arm B - Anti LAG-3 Single Agent
- Group 3: Arm B:Combination Anti LAG-3 +Pomalidomide+Dexamethasone
- Group 4: Arm C - Anti-TIGIT Single Agent
- Group 5: ARM C: Anti-TIGIT +Pomalidomide+Dexamethasone
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Are there any other ongoing research projects that concern Anti-LAG-3?
"In 2002, Anti-LAG-3 was first researched at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. 1131 studies have been completed to date and 636 are still recruiting participants, many of which are in Ann Arbor, Michigan."
Answered by AI
What is the highest number of people who can be enrolled in this clinical trial?
"That is correct. The online information regarding this clinical trial reveals that it is still recruiting patients. This experiment was originally posted on June 30th 2020 and updated September 9th 2021. They are looking for a total of 104 individuals from 10 different locations."
Answered by AI
What are the common applications for Anti-LAG-3?
"Anti-LAG-3 is a medication used to treat conditions that cause inflammation of the eye, blockage of veins in the retina, and swelling of the macula."
Answered by AI
In how many different medical institutions is this research being conducted?
"Right now, this study is being conducted at 10 different research centres. The locations are: Ann Arbor, Atlanta and Boston plus 7 other cities. If you want to take part in this trial, try and select a location that is nearby to help manage travel requirements."
Answered by AI
Are participants still being accepted for this research?
"The most recent information on clinicaltrials.gov affirms that this study is presently recruiting individuals for participation. This trial was originally posted on 6/30/2020 and has been updated as recently as 9/9/2021. The research team is seeking a total of 104 participants across 10 different sites."
Answered by AI
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