Your session is about to expire
← Back to Search
Monoclonal Antibodies
TTI-622 + Daratumumab for Multiple Myeloma
Phase 1
Waitlist Available
Led By Alexander Lesokhin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate Liver Function as defined by specific criteria
Adequate Renal Function as defined by specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test the safety of a new combination drug to treat multiple myeloma.
Who is the study for?
This trial is for adults with relapsed/refractory multiple myeloma who have tried at least three prior treatments and meet specific health criteria. They must not have had major surgery or radiation therapy recently, no other cancers, and can't be pregnant or unwilling to use contraception.Check my eligibility
What is being tested?
The study tests the safety of TTI-622 combined with daratumumab hyaluronidase-fihj to find the highest dose that's safe with few side effects. After determining this dose, its effectiveness in treating multiple myeloma will be evaluated.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation, infusion-related responses, and impacts on blood counts. Specific side effect profiles will be determined during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is working well.
Select...
My kidney function is within normal ranges.
Select...
I am 18 years old or older.
Select...
I have undergone at least 3 treatments and have taken specific medications before.
Select...
My multiple myeloma has returned or is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities
Secondary outcome measures
Overall response of TTI-621
Overall response of TTI-622
Trial Design
2Treatment groups
Experimental Treatment
Group I: TTI-622 dosing will occur over 8 weeks + Daratumumab Hyaluronidase-fihjExperimental Treatment2 Interventions
TTI-622 will be administered weekly at the assigned dose levels per the ramp-up schedule. Daratumumab hyaluronidase-fihj 1800 mg will administered on a standard schedule consisting of weekly administration for 8 weeks, every other week administration for 16 weeks, followed by every 4-week administration thereafter.
Group II: TTI-622 dosing will occur over 4 weeks + Daratumumab Hyaluronidase-fihjExperimental Treatment2 Interventions
TTI-622 will be administered weekly at the assigned dose levels per the ramp-up schedule. Daratumumab hyaluronidase-fihj 1800 mg will administered on a standard schedule consisting of weekly administration for 8 weeks, every other week administration for 16 weeks, followed by every 4-week administration thereafter.
Find a Location
Who is running the clinical trial?
Trillium Therapeutics Inc.Industry Sponsor
6 Previous Clinical Trials
596 Total Patients Enrolled
1 Trials studying Multiple Myeloma
177 Patients Enrolled for Multiple Myeloma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,615 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,160 Patients Enrolled for Multiple Myeloma
Alexander Lesokhin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
108 Total Patients Enrolled
1 Trials studying Multiple Myeloma
108 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack or stroke in the last 6 months.My side effects from previous treatments have mostly gone away.I do not have any severe medical or mental health issues currently.Women who can have children must have a negative pregnancy test when they are screened for the study.My liver is working well.I have not had radiation therapy in the last 2 weeks.My blood counts are within a healthy range.You have a condition that weakens your immune system from birth.I can care for myself but may not be able to do heavy physical work.I have not had major surgery in the last 4 weeks.My body does not respond to blood or platelet transfusions.I have not received monoclonal antibody therapy recently.My kidney function is within normal ranges.I am 18 years old or older.I had a stem cell transplant less than 100 days ago.You do not have certain markers for Hepatitis B in your blood.Patients must have a condition that can be measured using specific guidelines.I do not have any active, uncontrolled infections or HIV/AIDS-related illnesses.I have multiple myeloma and may have another type of cancer.I have undergone at least 3 treatments and have taken specific medications before.I have not had a donor lymphocyte infusion in the last 30 days.I have an autoimmune disorder that needs treatment.My multiple myeloma has returned or is not responding to treatment.You do not have antibodies for hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: TTI-622 dosing will occur over 8 weeks + Daratumumab Hyaluronidase-fihj
- Group 2: TTI-622 dosing will occur over 4 weeks + Daratumumab Hyaluronidase-fihj
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.
Could you elaborate on previous investigations that have been conducted with Daratumumab Hyaluronidase-fihj?
"The initial research on Daratumumab Hyaluronidase-fihj was conducted in the Mayo Clinic during 2012. At present, 50 trials have been finalized with 143 ongoing investigations taking place primarily in Middletown, New york."
Answered by AI
What conditions are usually treated with Daratumumab Hyaluronidase-fihj?
"Daratumumab Hyaluronidase-fihj is administered to treat cell transplants, as well as immunomodulation, improved absorption and dispersion of other drugs injected into the body, and urography."
Answered by AI
How likely are adverse effects when taking Daratumumab Hyaluronidase-fihj?
"The safety profile of Daratumumab Hyaluronidase-fihj was assessed as a 1, since this is only an early stage trial. Thus far there has been limited data collected on both efficacy and security."
Answered by AI
Are enrollment slots available for this clinical exploration?
"Yes, the details on clinicaltrials.gov illustrate that this study is still open for enrollment. The trial was initially published on October 28th 2021 and has been modified as recently as May 9th 2022. 32 participants are required at nine different healthcare facilities."
Answered by AI
How many healthcare facilities are involved in this trial's implementation?
"Currently, 9 sites are offering participation in this clinical trial. These locations include Memorial Sloan Kettering Monmouth (Middletown), Memorial Sloan Kettering Cancer Center (Uniondale) and Memorial Sloan Kettering Nassau (Montvale). Additionally, there are 6 other eligible medical centres."
Answered by AI
How many participants are receiving treatment with this clinical trial?
"Affirmative, the information available from clinicaltrials.gov reveals that this medical investigation is actively seeking volunteers. This trial was first published on October 28th 2021 and has had its most recent update on May 9th 2022. 32 participants need to be enrolled across nine different sites."
Answered by AI
Who else is applying?
What state do they live in?
Hawaii
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger