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SAR442257 for Multiple Myeloma and Non-Hodgkin Lymphoma
Study Summary
This trial is testing a new drug for people with multiple myeloma or non-Hodgkin lymphoma who have not responded to other treatments. The goal is to find the highest dose of the drug that is safe and to see if it has any effect against the cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have had 3 types of treatments for my condition, including PI, IMiD, and anti-CD38.I have advanced cutaneous T cell lymphoma with no standard treatment options left.I do not have an ongoing infection needing treatment now or in the last 14 days.My condition is a type of T cell lymphoma.I have been diagnosed with diffuse large B-cell lymphoma.I have relapsed or refractory multiple myeloma.I can take care of myself but might not be able to do heavy physical work.I have a type of non-Hodgkin lymphoma with a tumor larger than 1.5 cm.I have been diagnosed with mantle cell lymphoma.I have been diagnosed with follicular lymphoma.My condition is marginal zone lymphoma.I have been diagnosed with diffuse large B-cell lymphoma.My multiple myeloma has not responded to or I cannot tolerate standard treatments.I can take care of myself and am up and about more than half of my waking hours.My condition is transformed follicular lymphoma.I am at least 18 years old or the legal adult age in my country.I have been diagnosed with follicular lymphoma.My condition worsened within 60 days after my last anti-CD38 antibody treatment.My multiple myeloma is measurable by medical tests.My condition is transformed follicular lymphoma.I have been diagnosed with lymphoplasmacytic lymphoma.My cancer is a specific type of immune system cancer linked to breast implants or affects my intestines, liver, or spleen.My heart pumps well and I don't have fluid around it, confirmed by an ECHO.My non-Hodgkin lymphoma has not responded to or cannot tolerate standard treatments.I haven't had cancer, except for certain skin cancers or low-risk types, in the last 3 years.My lymphoma is one of the specified types (AITL, ALCL, adult T-cell leukemia-lymphoma, or peripheral TCL NOS).I can provide a tissue sample from my lymphoma for testing, and if treated, I can provide another during the study.I can provide a tissue sample from my lymphoma for testing.My condition is a type of T cell lymphoma.My condition worsened within 60 days after my last anti-CD38 antibody treatment.My multiple myeloma has not responded to or I cannot tolerate standard treatments.I have an autoimmune disease that needs more than 10 mg of prednisone daily.I am HIV positive and have lasting side effects from cancer treatment.My lymphoma involves MYC, BCL2, or BCL6 rearrangement.I have advanced cutaneous T cell lymphoma with no standard treatment options left.I have been diagnosed with small lymphocytic lymphoma.I have a condition affecting my brain or nervous system, such as amyloidosis, leukemia, or a movement disorder.I have been diagnosed with mantle cell lymphoma.I have been diagnosed with small lymphocytic lymphoma.My cancer is a specific type affecting the immune system and related to breast implants or certain organs.I have a type of non-Hodgkin lymphoma with a tumor larger than 1.5 cm.I have had 3 types of treatments for my condition, including PI, IMiD, and anti-CD38 mAb.My heart pumps well and I don't have fluid around it, confirmed by an ECHO.I have serious heart issues, including recent heart attack or uncontrolled blood pressure.My lymphoma involves MYC, BCL2, or BCL6 rearrangement.My condition is a type of T-cell lymphoma.I have relapsed or refractory multiple myeloma.My condition is marginal zone lymphoma.I have been diagnosed with lymphoplasmacytic lymphoma.My multiple myeloma is measurable by medical tests.You are expected to live for at least 3 months (12 weeks).I am at least 18 years old or the legal adult age in my country.My non-Hodgkin lymphoma has not responded to or cannot tolerate standard treatments.
- Group 1: Dose escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What outcomes are researchers striving to attain with this experiment?
"Primarily, this clinical trial seeks to identify the maximum tolerated dose over a projected 4 month period. In addition to that objective, it will also assess pharmacokinetic parameters (AUC0-τ), overall response rate for RRMM according to IMWG 2016 criteria, and incidence of anti-drug antibodies (ADA) against SAR442257."
What is the aggregate number of participants in this clinical research?
"This medical study seeks 57 participants that meet the given inclusion criteria. Patients can sign up at multiple facilities such as Mayo Clinic of Rochester-Site Number:8400003 in Rochester, Minnesota and City of Hope-Site Number:8400001 located in Duarte, California."
Are there remaining vacancies in this trial that patients can apply to?
"Affirmative. Clinicaltrials.gov displays the information that this clinical trial, which was posted on July 24th 2020, is currently seeking applicants. The research requires 57 individuals to be recruited from 8 individual sites."
What is the regulatory status of SAR442257?
"Preliminary evidence suggests SAR442257 is relatively safe, so it was given a score of 1. This being said, as this is only a Phase 1 trial there are limited data supporting safety and efficacy."
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