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Corticosteroid
Immunomodulatory Drugs + Corticosteroid for Multiple Myeloma
Phase 2
Waitlist Available
Led By Wilson I. Gonsalves, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
COHORT A: Untreated smoldering multiple myeloma with specific criteria
Calculated creatinine clearance >= 45 ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial is testing immunomodulatory drugs in combination with a corticosteroid drug to treat multiple myeloma or smoldering multiple myeloma.
Who is the study for?
This trial is for adults with multiple myeloma, either untreated smoldering, newly diagnosed needing treatment, or relapsed/refractory after specific therapies. Participants must meet certain health criteria like blood counts and liver function, be willing to provide samples for research, follow REMS program requirements if on Pomalyst, and not be pregnant or nursing.Check my eligibility
What is being tested?
The study tests immunomodulatory drugs (Lenalidomide alone or with Pomalidomide) combined with a corticosteroid (Dexamethasone) in treating multiple myeloma. It aims to determine the best drug combinations by observing patient responses to one treatment cycle of these medications.See study design
What are the potential side effects?
Potential side effects may include immune system changes due to Lenalidomide and Pomalidomide; Dexamethasone can cause strong anti-inflammatory reactions. Specific side effects are not listed but typically align with those associated with immunotherapy and steroids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have untreated smoldering multiple myeloma.
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My kidneys are functioning well enough to clear waste.
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I can care for myself but may not be able to do heavy physical work.
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My multiple myeloma has returned or didn't respond to treatment.
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My cancer can be measured by medical tests.
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I am 18 years old or older.
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My multiple myeloma has returned or didn't respond to treatment.
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I am being considered for treatment that includes IMiDs.
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I have newly diagnosed myeloma and haven't received any treatments yet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rates (RR)
Secondary outcome measures
Depth of hematological responses
Predictive biomarkers
Response rates (RR) among African American (AA) and white patients
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort D (lenalidomide, dexamethasone, pomalidomide)Experimental Treatment4 Interventions
Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.
Group II: Cohort C (lenalidomide, dexamethasone, pomalidomide)Experimental Treatment4 Interventions
Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Cohort B (lenalidomide, dexamethasone)Experimental Treatment3 Interventions
Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.
Group IV: Cohort A (lenalidomide, dexamethasone)Experimental Treatment3 Interventions
Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Lenalidomide
FDA approved
Pomalidomide
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,629 Total Patients Enrolled
572 Trials studying Multiple Myeloma
187,968 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,034 Total Patients Enrolled
75 Trials studying Multiple Myeloma
9,494 Patients Enrolled for Multiple Myeloma
Wilson I. Gonsalves, M.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood clotting time is within a certain range.I have untreated smoldering multiple myeloma.My kidneys are functioning well enough to clear waste.I can care for myself but may not be able to do heavy physical work.My cancer can be measured by medical tests.I am 18 years old or older.My multiple myeloma has returned or didn't respond to treatment.I am being considered for treatment that includes IMiDs.Your total bilirubin level is not more than 1.5 times the upper limit of normal.Your platelet count is at least 100,000 per cubic millimeter.You are taking any other experimental medication for your main type of cancer.I had a heart attack less than 6 months ago.My multiple myeloma has returned or didn't respond to treatment.Your hemoglobin level is at least 9.0 grams per deciliter.Your body has enough white blood cells called neutrophils.I am immunocompromised or HIV positive and on antiretroviral therapy.I do not have any severe illnesses besides my current condition.Your liver enzyme levels (ALT and AST) are within a certain range.I do not have any unmanaged ongoing illnesses.Women who can have children must have a negative pregnancy test within 7 days before joining the study.I have newly diagnosed myeloma and haven't received any treatments yet.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A (lenalidomide, dexamethasone)
- Group 2: Cohort B (lenalidomide, dexamethasone)
- Group 3: Cohort C (lenalidomide, dexamethasone, pomalidomide)
- Group 4: Cohort D (lenalidomide, dexamethasone, pomalidomide)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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 health risks associated with Bone Marrow Biopsy?
"Our analysts evaluated Bone Marrow Biopsy's safety to be a 2, as the Phase 2 trial provides evidence of its safety but does not yet have any data on efficacy."
Answered by AI
Is there still an opportunity for individuals to participate in this research?
"Affirmative. Clinicaltrials.gov shows that this experiment, which was first publicised on 3/22/2022, is actively enrolling participants. Approximately 190 candidates need to be enrolled from 3 distinct clinical centres."
Answered by AI
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