Cytarabine for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Multiple MyelomaCytarabine - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Ascorbate
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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 12 months

12 months
Complete Response Rate
Hospitalization Duration
Overall Survival
Progression Free Survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Next Generation Sequencing
1
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1
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Side Effects for

Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
79%Neutrophil count decreased
43%Anemia
29%Platelet count decreased
22%Febrile neutropenia
22%White blood cell decreased
14%Infections and infestations - Other, specify
10%Blood and lymphatic system disorders - Other, specify
9%Lymphocyte count decreased
4%Anaphylaxis
4%Mucositis oral
4%Nausea
3%Vomiting
3%Catheter related infection
3%Hypokalemia
2%Pain
2%Carbon monoxide diffusing capacity decreased
2%Hyponatremia
2%Dehydration
2%Abdominal pain
2%Diarrhea
2%Hypotension
2%Thromboembolic event
1%Blood bilirubin increased
1%Personality change
1%Ileus
1%Typhlitis
1%Alanine aminotransferase increased
1%Hyperkalemia
1%Hypoglycemia
1%Hypophosphatemia
1%Headache
1%Neuralgia
1%Peripheral motor neuropathy
1%Syncope
1%Anxiety
1%Dyspnea
1%Hypoxia
1%Peripheral sensory neuropathy
1%Hyperglycemia
1%Colitis
1%Fatigue
1%Fever
1%Bone pain
1%Myalgia
1%Hypertension
This histogram enumerates side effects from a completed undefined Phase 3 trial (NCT00025259) in the Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) ARM group. Side effects include: Neutrophil count decreased with 79%, Anemia with 43%, Platelet count decreased with 29%, Febrile neutropenia with 22%, White blood cell decreased with 22%.

Trial Design

2 Treatment Groups

Melphalan Regimen- Control Arm
1 of 2
BEAM Regimen- Experimental Arm
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Cytarabine · No Placebo Group · Phase 2

BEAM Regimen- Experimental ArmExperimental Group · 4 Interventions: Etoposide, Cytarabine, Carmustine, Allopurinol · Intervention Types: Drug, Drug, Drug, Drug
Melphalan Regimen- Control ArmActiveComparator Group · 2 Interventions: Melphalan, Allopurinol · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Cytarabine
FDA approved
Carmustine
FDA approved
Allopurinol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Swedish Medical CenterLead Sponsor
51 Previous Clinical Trials
8,019 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

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References

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