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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
Must not have
Uncontrolled infection
Planned tandem autologous/reduced intensity allograft
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any infections that aren't responding to treatment.
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I am scheduled for a specific bone marrow transplant procedure.
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I don't have enough stem cells stored for a transplant.
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I have a history of seizures.
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I have had cancer before, but my life expectancy is less than 3 years due to it.
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My myeloma has spread to my brain and is not under control.
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My health is severely impacted by a life-threatening condition.
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I have had a stem cell transplant using my own cells.
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I have been diagnosed with amyloidosis.
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I am unable to understand or make decisions about my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 • NCT00025259
80%
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%
Myalgia
1%
Depression
1%
Hypoxia
1%
Hyponatremia
1%
Immune system disorders - Other, specify
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)

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
54 Previous Clinical Trials
8,394 Total Patients Enrolled

Media Library

Carmustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03570983 — Phase 2
Multiple Myeloma Research Study Groups: BEAM Regimen- Experimental Arm, Melphalan Regimen- Control Arm
Multiple Myeloma Clinical Trial 2023: Carmustine Highlights & Side Effects. Trial Name: NCT03570983 — Phase 2
Carmustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03570983 — Phase 2
~15 spots leftby Jul 2025
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