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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
Must not have
Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception
Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant
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
No Placebo-Only Group
Pivotal Trial
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.
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.
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.
Select...
I can have a bone marrow test after signing up.
Select...
My institution has the Clonality test results from Adaptive Biotechnologies.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
I have COPD and my recent lung function test shows FEV1 greater than 50% of the normal prediction.
Select...
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.
Select...
I've had only one round of chemotherapy and limited steroids for my myeloma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am using effective birth control and do not plan to conceive.
Select...
I have not had treatments outside my initial therapy plan, including stem cell transplant.
Select...
I haven't had moderate or severe asthma, or uncontrolled asthma in the last 2 years.
Select...
I am a man and I do not plan to father children because I practice true abstinence.
Select...
I am not pregnant or breastfeeding.
Select...
I am not on any other chemotherapy or experimental treatments.
Select...
I do not have severe nerve damage or mild nerve damage with pain.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Consolidation overall survival
Secondary study objectives
Consolidation progression-free survival
FACT-Ntx TOI recovery rate (Patient reported outcome [PRO])
Other study objectives
Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome)
Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO)
PRO completion rate
+2 moreSide effects data
From 2022 Phase 3 trial • 402 Patients • NCT0311056243%
Weight decreased
29%
Cough
29%
Thrombocytopenia
29%
Decreased appetite
29%
Nausea
21%
Fatigue
21%
Anaemia
21%
Constipation
21%
Diarrhoea
14%
Neuropathy peripheral
14%
Oedema peripheral
14%
Pneumonia
14%
Paraesthesia
14%
Cataract
14%
Vomiting
14%
Headache
7%
Bronchiectasis
7%
Disturbance in attention
7%
Respiratory syncytial virus infection
7%
Neutropenia
7%
Peripheral swelling
7%
Mental status changes
7%
Lower respiratory tract infection
7%
Asthma
7%
Back pain
7%
Pain in extremity
7%
Basal cell carcinoma
7%
Hyponatraemia
7%
Skin lesion
7%
Oropharyngeal pain
7%
Pyrexia
7%
Cardiac failure
7%
Hepatitis
7%
Pharyngitis
7%
Hypophagia
7%
Pollakiuria
7%
Urinary tract infection
7%
Non-cardiac chest pain
7%
C-reactive protein increased
7%
Taste disorder
7%
Haemorrhagic transformation stroke
7%
Abdominal pain
7%
Insomnia
7%
Dyspepsia
7%
Haemoglobin decreased
7%
Infection
7%
Hyperglycaemia
7%
Toothache
7%
Ecchymosis
7%
Upper respiratory tract infection
7%
Nasopharyngitis
7%
Fungal skin infection
7%
Viral infection
7%
Hypertension
7%
Muscular weakness
7%
Hyperthyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
SdX Arm: Selinexor + Dexamethasone
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone
Awards & Highlights
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.
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
~2650
Lenalidomide
2005
Completed Phase 3
~2240
Bortezomib
2005
Completed Phase 3
~1410
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
120 Previous Clinical Trials
178,427 Total Patients Enrolled
3 Trials studying Multiple Myeloma
1,975 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,015,349 Total Patients Enrolled
594 Trials studying Multiple Myeloma
189,600 Patients Enrolled for Multiple Myeloma
Shaji K KumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group
6 Previous Clinical Trials
346 Total Patients Enrolled
6 Trials studying Multiple Myeloma
346 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.
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