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Corticosteroid
Gossypol + Lenalidomide + Dexamethasone for Multiple Myeloma
Phase 1
Waitlist Available
Led By Asher Chanan-Khan
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of R-(-)-gossypol acetic acid given with lenalidomide and dexamethasone to treat patients with multiple myeloma that has returned or gotten worse after treatment.
Who is the study for?
This trial is for patients with relapsed symptomatic multiple myeloma who have had at least one prior treatment. They must have a certain level of kidney function, blood cell counts, and be able to provide consent. Pregnant or breastfeeding individuals, those unwilling to use contraception, or with other serious health issues are excluded.Check my eligibility
What is being tested?
The study tests the combination of R-(-)-gossypol acetic acid with lenalidomide and dexamethasone in treating multiple myeloma that has returned after treatment. It aims to find the safest dose while assessing how well this combo works against cancer cells.See study design
What are the potential side effects?
Potential side effects may include immune system changes, increased risk of infection due to low blood cell counts, possible organ inflammation from immune reactions, fatigue from chemotherapy drugs like dexamethasone, and specific risks associated with each drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximally tolerated dose of AT-101 in combination with lenalidomide and dexamethasone defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (Phase I)
Overall response rate, with response defined to be a stringent complete response, complete response, very good partial response, or partial response (Phase II)
Secondary outcome measures
Incidence of adverse events
Overall survival (Phase II)
Progression free survival (Phase II)
Other outcome measures
Biochemical response, measured by change in serum/urine M-proteins and light chains
Change in Cereblon expression
Change in basal expression of Bcl-2 and its family members
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (AT-101, lenalidomide, and dexamethasone)Experimental Treatment5 Interventions
Patients receive R-(-)-gossypol acetic acid PO QD on days 1-21. Beginning in course 2, patients also receive lenalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, and 15 of courses 2-12. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 2
~1070
R-(-)-Gossypol Acetic Acid
2016
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,354 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,415 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,239 Previous Clinical Trials
3,771,589 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,701 Patients Enrolled for Multiple Myeloma
Asher Chanan-KhanPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma.You have already tried more than three different treatments for multiple myeloma.You have another type of cancer that is currently being treated, except for non-melanoma skin cancer or early-stage cervical cancer. If you had cancer in the past, you are not currently receiving treatment for it.I'm not sure what specific criterion you are referring to. Can you provide more details or context?You have other health problems that would make it difficult for you to take part in the trial, like uncontrolled infection or serious heart or lung disease.You are not currently receiving any other experimental treatments, but you can still take bisphosphonates for support.You had a severe skin reaction to similar drugs before.You have medical issues that make it unsafe for you to take medicine to prevent blood clots while being treated with lenalidomide.You have current heart problems that are not under control, such as irregular heartbeat, heart failure, chest pain, or heart attack within the last 6 months.You have been diagnosed with HIV.Your kidneys are working well enough, with a clearance of at least 60 mL of creatinine per minute.You must have a certain level of white blood cells called neutrophils in your body.Your platelet count is at least 75,000 per cubic millimeter.Your hemoglobin level is at least 8.0 grams per deciliter.You have multiple myeloma that has come back and is causing symptoms.You must have a measurable disease of multiple myeloma, which means that it can be seen and measured by the doctors.Your blood test shows high levels of certain proteins and an unusual ratio of other proteins.You have a high level of a specific type of protein in your blood.You have more than 200 milligrams of monoclonal protein in your urine over a 24-hour period.You are able to perform daily activities without any problems (ECOG performance status 0, 1, or 2).You have already been treated with at least one previous medication.Women who can have babies must have a negative pregnancy test within 7 days before joining the study.You agree to give samples of your bone marrow and blood for research.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (AT-101, lenalidomide, 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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