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Alkylating agents
BEAM vs. Melphalan for Multiple Myeloma (BEAM Trial)
Phase 2
Recruiting
Research Sponsored by Swedish Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky >70
Left ventricular ejection fraction >50%. No uncontrolled arrhythmias or symptomatic cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
BEAM Trial Summary
This trial aims to compare the effectiveness of two different treatments for multiple myeloma. The first treatment is the standard of care, which is Melphalan. The second treatment is BEAM, which has not been well studied in multiple myeloma specifically, but has been studied in other lymphomas. Early data suggests that BEAM may be effective in multiple myeloma, but there is not enough data to know for sure. This trial will help to determine whether BEAM is more effective than Melphalan.
Who is the study for?
This trial is for adults aged 18-70 with Multiple Myeloma who've had initial treatment and partial response. They must have certain levels of monoclonal proteins or plasma cells, be proficient in English, able to consent, and meet specific heart, lung, liver, kidney function criteria. Exclusions include cognitive impairment, insufficient stem cells for transplant, other malignancies with <3-year life expectancy, pregnancy/lactation, limited English proficiency.Check my eligibility
What is being tested?
The study compares the effectiveness of two chemotherapy regimens before autologous stem cell reinfusion in Multiple Myeloma patients: a single agent Melphalan versus BEAM (a combination of Carmustine, Etoposide, Cytarabine & Melphalan). It's a randomized trial aiming to determine which regimen leads to better outcomes like complete response rates and progression-free survival.See study design
What are the potential side effects?
Potential side effects may include nausea and vomiting from chemotherapy drugs; low blood counts leading to increased infection risk; mouth sores; hair loss; organ damage such as heart or lung complications; fatigue; allergic reactions. The severity can vary among individuals.
BEAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out normal activities.
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My heart pumps well and I don't have serious heart rhythm problems.
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My kidneys are functioning well.
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I am newly diagnosed with multiple myeloma and planning to undergo a stem cell transplant.
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My tests show more than 10% cancer cells in my bone marrow or a confirmed cancerous tumor.
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My lung function is good and I don't have breathing problems.
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You have dysfunction in your organs related to myeloma, such as high blood calcium, kidney problems, anemia, or bone issues.
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I am between 18 and 70 years old.
BEAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate
Secondary outcome measures
Hospitalization Duration
Overall Survival
Progression Free Survival
Side effects data
From undefined Phase 3 trial • 1734 Patients • NCT0002525980%
Neutrophil count decreased
42%
Anemia
31%
Platelet count decreased
26%
Febrile neutropenia
18%
White blood cell decreased
16%
Infections and infestations - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
5%
Lymphocyte count decreased
3%
Catheter related infection
3%
Dehydration
2%
Abdominal pain
2%
Mucositis oral
2%
Vomiting
2%
Anaphylaxis
2%
Hypokalemia
2%
Hypotension
1%
Depression
1%
Hyponatremia
1%
Immune system disorders - Other, specify
1%
Hypoxia
1%
Myalgia
1%
Dizziness
1%
Constipation
1%
Esophagitis
1%
Ileus
1%
Pain
1%
Carbon monoxide diffusing capacity decreased
1%
Hypoalbuminemia
1%
Neuralgia
1%
Peripheral sensory neuropathy
1%
Dyspnea
1%
Diarrhea
1%
Typhlitis
1%
Hyperglycemia
1%
Headache
1%
Seizure
1%
Syncope
1%
Nausea
1%
Cardiac disorders - Other, specify
1%
Hypophosphatemia
1%
Bone pain
1%
Peripheral motor neuropathy
1%
Thromboembolic event
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm III (RER With CR [ABVE-PC])
Arm I (Patients Off-therapy Before Callback-Induction Only)
Arm II (RER With CR [ABVE-PC, IFRT])
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
Arm VII (SER [ABVE-PC, IFRT])
Arm VI (SER [DECA, ABVE-PC, IFRT])
Arm V (RER With PD)
BEAM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BEAM Regimen- Experimental ArmExperimental Treatment4 Interventions
Allopurinol Dosage: Allopurinol 200 mg/m2/day starts on the day prior to BCNU, day -8 and stops on day -1.
BCNU (Carmustine) Dosage: Carmustine 300 mg/m2 IV x 1 will be infused over 3 hours on autografting day -7. Carmustine should not be infused with solutions or tubing containing or previously containing bicarbonate solution.
Etoposide (VP-16, Vepesid) Dosage: Etoposide 100 mg/m2 IV BID will be administered in 500-1000 cc normal saline over 2 hours on autografting days -6, -5, -4, and -3 for a total dose of 800 mg/m2. Etoposide may not be infused with sodium bicarbonate solutions.
Cytarabine (Ara-C) Dosage: Cytarabine 100 mg/m2 IV BID will be infused over 3 hours on autografting days -6, -5, -4 and -3.
Group II: Melphalan Regimen- Control ArmActive Control2 Interventions
Melphalan Dosage: Melphalan will be administered at a dose of 200 mg/m2 IV x 1 infused over 30 minutes on autografting day -2.
Allopurinol Dosage: Allopurinol 200 mg/m2/day starts on the day prior to melphalan (day -3) and stops on day -1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Cytarabine
2016
Completed Phase 3
~3310
Carmustine
1990
Completed Phase 3
~1790
Allopurinol
1999
Completed Phase 4
~6150
Find a Location
Who is running the clinical trial?
Swedish Medical CenterLead Sponsor
53 Previous Clinical Trials
8,194 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have HIV.My kidneys are functioning well.I have had cancer before, but my life expectancy is less than 3 years due to it.I do not have any infections that aren't responding to treatment.I am scheduled for a specific bone marrow transplant procedure.I don't have enough stem cells stored for a transplant.I am willing to use contraception if needed during the study.Your bilirubin levels are less than 2 mg/dl, and your SGPT levels are less than 2.5 times the normal range.There is a specific type of protein in your blood called M-protein.I have undergone at least 2 treatment cycles for my multiple myeloma and have seen some improvement.I have had a stem cell transplant using my own cells.My health is severely impacted by a life-threatening condition.I have a history of seizures.I am mostly able to care for myself and carry out normal activities.My heart pumps well and I don't have serious heart rhythm problems.My myeloma has spread to my brain and is not under control.I am newly diagnosed with multiple myeloma and planning to undergo a stem cell transplant.My lung function is good and I don't have breathing problems.My tests show more than 10% cancer cells in my bone marrow or a confirmed cancerous tumor.You have dysfunction in your organs related to myeloma, such as high blood calcium, kidney problems, anemia, or bone issues.I have been diagnosed with amyloidosis.I am unable to understand or make decisions about my treatment.I am between 18 and 70 years old.You do not have a serious illness that could greatly shorten your life.
Research Study Groups:
This trial has the following groups:- Group 1: BEAM Regimen- Experimental Arm
- Group 2: Melphalan Regimen- Control Arm
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 people currently being recruited for this experiment?
"Yes, as specified on clinicaltrials.gov, this trial is currently looking for volunteers. The listing was created on September 5th, 2018 and was edited most recently on June 21st, 2022. They are 100 individuals needed to complete the study at 1 location."
Answered by AI
Has Cytarabine been cleared by the FDA for public consumption?
"While Phase 2 trials are not as reliable in terms of efficacy, the data collected thus suggest that Cytarabine is safe."
Answered by AI
For what purpose is Cytarabine most commonly prescribed?
"Various forms of cancer, including small cell lung cancer (sclc), leukemia, myelocytic, acute, and neuroblastoma (nb) can all be treated with Cytarabine."
Answered by AI
How many individuals are being recruited for this clinical research?
"Yes, the information on clinicaltrials.gov indicates that this trial is actively recruiting patients. The trial was first posted on September 5, 2018 and was most recently updated on June 21, 2022. The study is looking for 100 participants across 1 site."
Answered by AI
Might I be eligible to participate in this clinical research?
"Eligibility for this study requires a cancer diagnosis of multiple myeloma and being between 18-70 years old. A total of 100 people are needed for the clinical trial."
Answered by AI
Does this research include patients that are over 55 years old?
"This particular trial is only seeking patients aged 18-70. Out of the 772 total trials, 250 are for individuals below 18 years old and 1222 are for seniors above 65."
Answered by AI
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