Your session is about to expire
← Back to Search
Proteasome Inhibitor
Combination Chemotherapy for Multiple Myeloma
Phase 2
Recruiting
Led By Shaji K. Kumar, 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
Patient must have suspected or confirmed newly diagnosed multiple myeloma by International Myeloma Working Group (IMWG) criteria
High risk myeloma, which is untreated, defined as any two of: International Staging System (ISS) stage 3, Gain or amplification of chr1q, del17p, t(4;14) or t(14;16), >= 5% circulating plasma cells
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration to death due to any cause, assessed up to 10 years
Awards & highlights
Study Summary
This trial tests whether a combination of chemotherapy drugs can improve blood test results in patients with high-risk multiple myeloma. The drugs work in different ways to stop the growth of cancer cells. This trial may help determine if patients who have a small amount of cancer left after the initial treatment will benefit from the drug combination.
Who is the study for?
Adults aged 18-80 with newly diagnosed high-risk multiple myeloma, able to perform daily activities (ECOG PS 0 or 1), and have not had significant treatment yet. Participants must be willing to provide samples for research, take daily aspirin, and have a life expectancy over 6 months. They should not have severe allergies to trial drugs or their components, major surgery within the last two weeks, other serious medical conditions that could affect participation, or be pregnant/nursing without using contraception.Check my eligibility
What is being tested?
The REACH Trial is testing if a combination of chemotherapy drugs—carfilzomib, daratumumab, lenalidomide, and dexamethasone—can improve blood test results in patients with high-risk multiple myeloma after initial treatment has left minimal residual disease. The study includes imaging tests like CT scans and MRIs to monitor cancer progression.See study design
What are the potential side effects?
Possible side effects include fatigue; increased risk of infections; heart problems; liver issues reflected by changes in blood tests; nerve damage causing numbness or pain; allergic reactions; digestive disturbances such as nausea or constipation; low blood counts leading to bleeding risks or anemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma.
Select...
My myeloma is high risk and untreated, meeting at least two specific criteria.
Select...
I am fully active or can carry out light work.
Select...
I can take daily aspirin for blood clot prevention.
Select...
My white blood cell count is healthy without medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration to death due to any cause, assessed up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to death due to any cause, assessed up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of sustained minimal residual disease (MRD) negativity
Secondary outcome measures
Incidence of adverse events
Overall response rate (>= confirmed very good partial response ([VGPR])
Overall survival
+1 moreOther outcome measures
Bone marrow microenvironment
Clonal architecture before treatment
Side effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
Anaemia
49%
Upper respiratory tract infection
49%
Platelet count decreased
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Hyperuricaemia
17%
Diarrhoea
16%
Hypoalbuminaemia
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Blood lactate dehydrogenase increased
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Alanine aminotransferase increased
11%
Hyponatraemia
11%
Hypercalcaemia
10%
Aspartate aminotransferase increased
10%
Blood potassium decreased
10%
Bronchitis
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Peripheral swelling
7%
Nasopharyngitis
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Thrombocytopenia
6%
Vision blurred
6%
Respiratory tract infection
6%
Hepatic function abnormal
6%
Nausea
6%
Hypoglycaemia
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Cardiac amyloidosis
2%
Localised infection
1%
Pain
1%
Periodontitis
1%
Myelopathy
1%
Device related infection
1%
Dysuria
1%
Pleural effusion
1%
Otitis media
1%
Pancreatitis acute
1%
Spinal compression fracture
1%
Lipoma
1%
Cerebral ischaemia
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Soft tissue infection
1%
Nerve compression
1%
Chronic kidney disease
1%
Hypotension
1%
Asthma
1%
Bronchiolitis
1%
Pathological fracture
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (combination chemotherapy)Experimental Treatment8 Interventions
INDUCTION: Patients receive carfilzomib IV on days 2, 8, and 15 of cycle 1 and days 1, 8, and 15 of cycles 2-12, lenalidomide PO days 1-21 of each cycle, daratumumab SC days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles, and dexamethasone PO or IV on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive carfilzomib IV on days 1, 8, and 15, lenalidomide PO days 1-21, daratumumab SC day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive carfilzomib IV on day 1, lenalidomide PO days 1-21, daratumumab day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy, MRI and, CT/PET.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Computed Tomography
2017
Completed Phase 2
~2720
Daratumumab
2014
Completed Phase 3
~1860
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,065 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,636 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,606 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,056 Patients Enrolled for Multiple Myeloma
Shaji K. Kumar, M.D.Principal InvestigatorMayo Clinic in Rochester
8 Previous Clinical Trials
2,704 Total Patients Enrolled
8 Trials studying Multiple Myeloma
2,704 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your total bilirubin level needs to be within a certain range, as measured within the last 14 days before joining the study.Your heart's pumping ability (LVEF) should be between 40% and 30% within the last 30 days before pre-registration.I am HIV positive.My kidney function, measured by creatinine clearance, is adequate.I have not had major surgery in the last 14 days.I have heart failure that affects my daily activities.I do not have uncontrolled heart problems.I have severe nerve damage or moderate with recent pain.I am allergic to corticosteroids, monoclonal antibodies, human proteins, or their components.I have been diagnosed with multiple myeloma.I have a blood disorder but it's not actively harming my organs.I have tested positive for hepatitis B or have had it in the past.Your platelet count is at least 75,000 per cubic millimeter, as tested within the last 14 days before joining the study.I do not have any major health issues that would prevent me from joining the trial.My myeloma is high risk and untreated, meeting at least two specific criteria.You are expected to live for at least 6 more months.Your liver enzymes (ALT and AST) are not more than three times the normal limit.I have not been diagnosed or treated for another cancer within the last year and have no signs of remaining cancer.I am between 18 and 80 years old.I am fully active or can carry out light work.You are currently receiving any other experimental treatments or chemotherapy.I have or might have an active hepatitis C infection.Your hemoglobin level is 8.0 grams per deciliter or higher.I can take daily aspirin for blood clot prevention.My white blood cell count is healthy without medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (combination chemotherapy)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open positions for test subjects in this clinical trial?
"That is correct. The information available on clinicaltrials.gov verifies that this study is looking for new participants. This trial was originally posted on September 22, 2022 and edited September 23, 75 people are needed from 2 different locations."
Answered by AI
Has Carfilzomib been cleared by the FDA for public consumption?
"Carfilzomib's safety is based on Phase 2 trial data, which means that while there is some evidence to support its safety, there is none to suggest that it is effective."
Answered by AI
Could I possibly take part in this clinical research?
"This study is admitting 75 patients with multiple myeloma who meet the following criteria: age 18-80, left ventricular ejection fraction (LVEF) >= 40% within the last 30 days, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, willing to provide informed written consent, willing to return for follow-up during active treatment phase of trial, able to take aspirin daily as prophylactic anticoagulation (325 mg), life expectancy > 6 months."
Answered by AI
Is age a factor in this clinical trial?
"Eligibility requirements state that potential participants must be between 18-80 years old. There are currently 41 trials underway for patients younger than 18 and 825 for those older than 65."
Answered by AI
How many people are being enrolled in this clinical trial?
"Correct, this research is recruiting individuals as the information available on clinicaltrials.gov indicates. The trial was initially posted on September 22nd, 2020 and updated September 23rd, 2020. They are looking for 75 people to participate at 2 sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger