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Proteasome Inhibitor
Combination Therapy for Multiple Myeloma
Phase 3
Recruiting
Led By Shaji K Kumar
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have standard risk MM as defined by the Revised International Staging System (RISS) stage I or II
Patient must be able to undergo diagnostic bone marrow aspirate following preregistration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years
Awards & highlights
Study Summary
This trial is testing a 4-drug combo vs. a 3-drug combo to see if the former is more effective in shrinking cancer or preventing its return.
Who is the study for?
Adults with newly diagnosed multiple myeloma who have completed initial treatment without progression, can undergo bone marrow tests, and have adequate organ function. They must not be pregnant or breastfeeding, agree to contraception if applicable, and have no severe allergies to trial drugs or their components.Check my eligibility
What is being tested?
The EQUATE trial is comparing a four-drug combo (daratumumab, bortezomib, lenalidomide & dexamethasone) against a three-drug regimen (daratumumab, lenalidomide & dexamethasone) for effectiveness in shrinking or preventing the return of multiple myeloma.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site for daratumumab and hyaluronidase-fihj; nerve damage from bortezomib; blood clots from lenalidomide; and increased infection risk due to immune system suppression by dexamethasone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma is considered standard risk, stage I or II.
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I can have a bone marrow test after signing up.
Select...
My institution has the Clonality test results from Adaptive Biotechnologies.
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My hepatitis B virus load is undetectable with treatment.
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I have COPD and my recent lung function test shows FEV1 greater than 50% of the normal prediction.
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I have been recently diagnosed with multiple myeloma.
Select...
I had hepatitis C but have been treated and cured.
Select...
My side effects from the first treatment are mild now.
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I've had only one round of chemotherapy and limited steroids for my myeloma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Consolidation overall survival
Secondary outcome measures
Best response
Consolidation progression-free survival
FACT-Ntx TOI recovery rate (Patient reported outcome [PRO])
+3 moreOther outcome measures
Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome)
Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO)
Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO)
+3 moreSide effects data
From 2008 Phase 2 trial • 20 Patients • NCT00006184100%
Injection site reaction
40%
Fatigue (asthenia, lethargy, malaise)
30%
Pruritus
30%
Platelets
30%
Chest pain (non-cardiac and non-pleuritic)
30%
Bone pain
30%
Headache
30%
Myalgia (muscle ache)
30%
SGPT (ALT)
30%
Abdominal pain or cramping
20%
Alkaline phosphatase
20%
Hypokalemia
20%
Dizziness/lightheadedness
20%
Arthralgia (joint pain)
20%
Hypomagnesemia
20%
Pain - Other
20%
Rash/desquamation
20%
Rigors/chills
20%
SGOT (AST)
10%
Hypoalbuminemia
10%
Hypocalcemia
10%
Hot flashes/flushes
10%
Hypophosphatemia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
10%
Lymphopenia
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Dry skin
10%
Constipation
10%
Hypotension
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Hypercalcemia
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Hematologic-Other (Splenomegaly in donor-resolved)
10%
Dyspnea (shortness of breath)
10%
Rash/desquamation for BMT
10%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor - Vaccination Generation Group
Recipient - Chemotherapy Group
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone)Experimental Treatment5 Interventions
CONSOLIDATION: Patients receive bortezomib SC on days 1, 8, and 15, daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21 and daratumumab SC on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (daratumumab, lenalidomide, dexamethasone)Active Control4 Interventions
INDUCTION: All patients receive standard induction therapy comprising the following: daratumumab subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7-9, lenalidomide orally (PO) daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Arm C (daratumumab, lenalidomide, dexamethasone)Active Control4 Interventions
CONSOLIDATION: Patients receive daratumumab SC on day 1, lenalidomide PO daily on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21, and daratumumab SC on day 1. Cycles repeats every 28 days 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 3
~1480
Bortezomib
2005
Completed Phase 2
~1140
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
175,472 Total Patients Enrolled
3 Trials studying Multiple Myeloma
1,975 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,924,555 Total Patients Enrolled
579 Trials studying Multiple Myeloma
187,681 Patients Enrolled for Multiple Myeloma
Shaji K KumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group
6 Previous Clinical Trials
289 Total Patients Enrolled
6 Trials studying Multiple Myeloma
289 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver function tests (ALT and AST) should be less than 3 times the upper limit of normal.My multiple myeloma is considered standard risk, stage I or II.Your kidneys are working well enough, with a certain amount of waste cleared from your blood every minute.Your platelet count is at least 75,000/mm^3 without needing a blood transfusion within the last 14 days.Your white blood cell count is at least 1000 per cubic millimeter.Your total bilirubin level should be within a certain range, as determined by the hospital's normal limits, when tested within 14 days before the study.Your hemoglobin level is at least 8 grams per deciliter.I can have a bone marrow test after signing up.I am using effective birth control and do not plan to conceive.My institution has the Clonality test results from Adaptive Biotechnologies.I have not had treatments outside my initial therapy plan, including stem cell transplant.My hepatitis B virus load is undetectable with treatment.I haven't had moderate or severe asthma, or uncontrolled asthma in the last 2 years.I have COPD and my recent lung function test shows FEV1 greater than 50% of the normal prediction.Your disease must be able to be measured or evaluated by the doctor.I completed my first treatment step and am registering for the next within 8 weeks.Your platelet count is 50,000 or more per cubic millimeter of blood. This should be checked within 14 days before the next step of the study.I have been recently diagnosed with multiple myeloma.You have finished the first part of the treatment without the disease getting worse.I have another cancer type, but it won't affect this trial's treatment.I don't have any serious health or mental conditions that could stop me from completing the treatment.I am a man and I do not plan to father children because I practice true abstinence.I had hepatitis C but have been treated and cured.I am HIV positive, on treatment, and my viral load is undetectable.Your hemoglobin level is at least 8.0 grams per deciliter within the last 14 days.I have had or have a blood clot and am willing to take blood thinners if not already.Your white blood cell count is at least 1000 per cubic millimeter.I am not pregnant or breastfeeding.I am not on any other chemotherapy or experimental treatments.Your kidney function, measured by creatinine clearance, needs to be above a certain level.My side effects from the first treatment are mild now.I do not have severe nerve damage or mild nerve damage with pain.I can care for myself, but my ability to move is limited due to pain.Your total bilirubin level should be less than 1.5 times the upper limit of normal as per the hospital's test.I have a history of heart issues or have been treated with heart-toxic drugs.Your liver enzymes (ALT and AST) are not more than 3 times the upper limit of normal, based on a blood test taken within 14 days before joining the study.I've had only one round of chemotherapy and limited steroids for my myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (daratumumab, lenalidomide, dexamethasone)
- Group 2: Arm C (daratumumab, lenalidomide, dexamethasone)
- Group 3: Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are the most popular functions of Bortezomib?
"Bortezomib is most often given to patients suffering from ophthalmia, sympathetic. However, it has also shown efficacy in treating branch retinal vein occlusion, macular edema, and other conditions where at least two prior systemic chemotherapy regimens have failed."
Answered by AI
Is Bortezomib only being studied for its potential in cancer treatment?
"Bortezomib's efficacy was first trialled in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since that time, there have been a total of 1794 completed trials worldwide. As of now, 841 different clinical trials are recruiting patients with a majority being based out of the states of Wyoming and Minnesota."
Answered by AI
Can people sign up to participate in the research at this time?
"Indeed, the medical research study detailed on clinicaltrials.gov is recruiting patients at this time. This particular trial was first made public on October 27th 2020 with the last update being December 1st 2021. They are currently looking for 1450 individuals across 100 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Minnesota
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Indu and Raj Soin Medical Center
How many prior treatments have patients received?
0
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