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Proteasome Inhibitor
Carfilzomib + Lenalidomide + Dexamethasone with Stem Cell Transplant for Multiple Myeloma
Phase 2
Waitlist Available
Led By Andrzej Jakubowiak
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed, myeloma requiring systemic chemotherapy as per International Myeloma Working Group (IMWG) uniform criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Must not have
Waldenstrom's macroglobulinemia or immunoglobin (Ig)M myeloma
Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is studying how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who can follow the study plan, including birth control and testing. They must have certain blood cell counts, organ function, and agree to not get pregnant or father a child. People with recent major surgery, other cancers within 3 years (except some skin cancers), heart issues, uncontrolled diabetes or hypertension, active infections, HIV or hepatitis cannot join.
What is being tested?
The trial tests carfilzomib, lenalidomide & dexamethasone before/after stem cell transplant in treating new multiple myeloma patients. Carfilzomib blocks enzymes cancer cells need; lenalidomide stimulates the immune system; dexamethasone kills or stops cancer cells from dividing.
What are the potential side effects?
Possible side effects include weakened immune system leading to infections; blood clots; nerve damage causing pain/numbness; allergic reactions to drugs used; fatigue and gastrointestinal issues like nausea/vomiting. Organ-specific inflammation may also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with myeloma and need chemotherapy.
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I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Waldenstrom's macroglobulinemia or IgM myeloma.
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I do not have severe nerve pain or damage.
Select...
My multiple myeloma shows low or no protein markers before treatment.
Select...
I have POEMS syndrome.
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I haven't been in a drug study within the last 3 weeks or 5 half-lives of the drug.
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I have not had major surgery in the last 3 weeks.
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My blood pressure or diabetes is not well-managed.
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I have not needed antibiotics or antivirals for an infection in the last two weeks.
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I am HIV positive.
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I cannot take certain medications like aspirin or warfarin due to allergies or past reactions.
Select...
I cannot undergo certain hydration treatments due to existing heart, lung, or kidney conditions.
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I have or might have amyloidosis in an organ.
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I need procedures to remove excess fluid from my chest or abdomen.
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I haven't had a heart attack in the last 6 months and don't have severe heart issues.
Select...
I cannot afford or my insurance does not cover lenalidomide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Patients Achieving sCR
Secondary study objectives
Duration of Response
Overall Response Rate, Defined as at Least a Partial Response to Therapy (> PR), at Least Very Good Partial Response (VGPR) and at Least Near Complete Response (nCR) Rate
Percentage of Participants With Overall Survival (OS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (dexamethasone, carfilzomib, lenalidomide)Experimental Treatment5 Interventions
INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity..
TRANSPLANT: Patients undergo autologous stem cell transplant.
CONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses 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
Carfilzomib
FDA approved
Lenalidomide
FDA approved
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,034 Previous Clinical Trials
753,618 Total Patients Enrolled
17 Trials studying Multiple Myeloma
2,343 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,924 Total Patients Enrolled
590 Trials studying Multiple Myeloma
189,281 Patients Enrolled for Multiple Myeloma
Andrzej JakubowiakPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
3 Previous Clinical Trials
243 Total Patients Enrolled
3 Trials studying Multiple Myeloma
243 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to mannitol in the past.You are expected to live for more than 3 months.I have Waldenstrom's macroglobulinemia or IgM myeloma.I haven't had cancer in the last 3 years, except for certain skin, thyroid, cervix, or low-grade prostate cancers.I do not have severe nerve pain or damage.I haven't been in a drug study within the last 3 weeks or 5 half-lives of the drug.I have not had major surgery in the last 3 weeks.My blood pressure or diabetes is not well-managed.I have not needed antibiotics or antivirals for an infection in the last two weeks.I need procedures to remove excess fluid from my chest or abdomen.I have been newly diagnosed with myeloma and need chemotherapy.I've been treated for myeloma or related conditions but haven't exceeded the specified medication limits.I haven't had radiotherapy to multiple sites or immunotherapy within the last 4 weeks.You currently have hepatitis A, B, or C infection.I am willing and able to undergo a stem cell transplant.My multiple myeloma shows low or no protein markers before treatment.I have POEMS syndrome.I cannot take certain medications like aspirin or warfarin due to allergies or past reactions.I cannot undergo certain hydration treatments due to existing heart, lung, or kidney conditions.I have or might have amyloidosis in an organ.I am HIV positive.I can take care of myself and am up and about more than half of my waking hours.I agree to use a condom during the study and for 28 days after, even if I've had a vasectomy.I can take aspirin or other medications to prevent blood clots.Your bilirubin levels are within the normal range.Your AST and ALT levels in your blood should be less than 2.5 times the upper limit of normal.My platelet count is at least 75, without transfusions for 2 weeks.I agree to regular pregnancy tests if I can have children.Your kidneys work well enough to filter at least 50 milliliters of waste from your blood every minute.Your body has enough white blood cells called neutrophils.I haven't had a heart attack in the last 6 months and don't have severe heart issues.Your hemoglobin level is at least 8 grams per deciliter.If you are able to have children, you need to have 2 negative pregnancy tests before starting lenalidomide.I cannot afford or my insurance does not cover lenalidomide.I am taking bisphosphonates.You have a disease that can be measured before starting treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (dexamethasone, carfilzomib, lenalidomide)
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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
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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