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Alkylating agents

Propylene Glycol-Free Melphalan Hydrochloride for Amyloidosis

Phase 2
Waitlist Available
Led By John M Sloan, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This study is evaluating whether a new drug may help treat a rare form of cancer.

Eligible Conditions
  • Amyloidosis

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
Number of Participants With Cardiac Dysfunction (New Arrhythmia)
Number of Participants With Renal Dysfunction
Secondary outcome measures
Hematologic Overall Response Rate
Neutrophil Engraftment
Organ Response
+3 more

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837
36%
Infection (grade 3 and above)
24%
Graft versus host disease
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

Trial Design

1Treatment groups
Experimental Treatment
Group I: EvomelaExperimental Treatment1 Intervention
Propylene Glycol-Free Melphalan Hydrochloride (Evomela) administered intravenously at 70-100 mg/m2/day on Days -3 and -2 prior to autologous stem cell transplantation

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
382 Previous Clinical Trials
869,372 Total Patients Enrolled
10 Trials studying Amyloidosis
1,032 Patients Enrolled for Amyloidosis
Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,162 Total Patients Enrolled
1 Trials studying Amyloidosis
46 Patients Enrolled for Amyloidosis
John M Sloan, MDPrincipal InvestigatorAttending Physician
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients
2018. "Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02994784.
~4 spots leftby Apr 2025
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