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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response Rate

Secondary study objectives

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

Blood and lymphatic system disorders - Other, specify

Lymphocyte count decreased

Catheter related infection

Dehydration

Abdominal pain

Mucositis oral

Vomiting

Anaphylaxis

Hypokalemia

Hypotension

Depression

Hyponatremia

Hypoxia

Myalgia

Immune system disorders - Other, specify

Dizziness

Constipation

Esophagitis

Ileus

Pain

Carbon monoxide diffusing capacity decreased

Hypoalbuminemia

Neuralgia

Peripheral sensory neuropathy

Dyspnea

Diarrhea

Typhlitis

Hyperglycemia

Headache

Seizure

Syncope

Nausea

Cardiac disorders - Other, specify

Hypophosphatemia

Bone pain

Peripheral motor neuropathy

Thromboembolic event

Hypertension

100%

80%

60%

40%

20%

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2960

Cytarabine

2016

Completed Phase 3

~3330