Trial · NCT02994784

Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients

NCT02994784, Phase 2, Terminated, Boston Medical Center; results first posted 2023-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients. Trials, record NCT02994784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02994784

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients
NCT number: NCT02994784
Status: Terminated
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: Boston Medical Center
Conditions: Amyloidosis; Systemic
Interventions: Propylene Glycol-Free Melphalan Hydrochloride
First posted: 2016-12-16
Last updated: 2023-05-24
Results first posted: 2023-05-24
Limitations and caveats: Study was halted early resulting in relatively small numbers of participants analyzed.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Renal Dysfunction	100 days	To determine the safety profile of propylene glycol-free melphalan hydrochloride in the conditioning regimen prior to autologous stem cell transplantation in AL amyloidosis patients, including adverse events related to renal dysfunction (was acute renal failure is defined as either a \>/=1 mg/dL increase in serum creatinine or a doubling of serum creatinine to \>/=1.5 mg/dL for at least 2 days.).
Primary	Number of Participants With Cardiac Dysfunction (New Arrhythmia)	100 days	To determine the safety profile of propylene glycol-free melphalan hydrochloride in the conditioning regimen prior to autologous stem cell transplantation in AL amyloidosis patients, including adverse events related to cardiac dysfunction (new arrhythmia).
Secondary	Neutrophil Engraftment	3 weeks	time to neutrophil engraftment
Secondary	Platelet Engraftment	100 days	Assess time to platelet engraftment
Secondary	Treatment Related Mortality	100 days	Number of patients who expire within 100 days of transplant
Secondary	Hematologic Overall Response Rate	6 months	Number of patients with response based on Gertz, Palladini criteria (below) Complete response (CR): Normal serum free light chain ratio,Negative serum and urine immunofixation electrophoresis Very good partial response (VGPR): Difference in serum free light chains less than 40 mg/L Partial Response (PR): \>50% Reduction in the difference in serum free light chains Stable Disease (SD): Meets neither criteria for CR, VGPR, PR or PD
Secondary	Organ Response	12 months	Number of patients with organ response based on Gertz criteria (below) * Kidney: 50% reduction in 24-hour urine protein excretion in the absence of progressive renal insufficiency (defined as a 25% increase in serum creatinine, as long as that is \> to an absolute increase of 0.5 mg/dL). In the case of nephrotic syndrome: a decrease in proteinuria to \< 1g/24h and an improvement in one of 2 extrarenal features - normalization of serum albumin or resolution of edema and/or discontinuation of diuretics in response to improvement in edema. * Heart: ≥ 2 mm reduction in the interventricular septal (IVS) thickness by echocardiogram, improvement of ejection fraction by ≥ 20% (echocardiogram must be performed at the same institution), or decrease in 2 NYHA classes without increase in diuretic need.
Secondary	Participants With Peri-transplant Hospitalizations	100 days	Number of participants with peri-transplant hospitalizations

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With Renal Dysfunction	100 days	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Cardiac Dysfunction (New Arrhythmia)	100 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Neutrophil Engraftment	3 weeks	days	MEDIAN
SECONDARY	Platelet Engraftment	100 days	days	MEDIAN
SECONDARY	Treatment Related Mortality	100 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hematologic Overall Response Rate	6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Organ Response	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants With Peri-transplant Hospitalizations	100 days	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Renal Dysfunction	Evomela	2		Participants
Number of Participants With Cardiac Dysfunction (New Arrhythmia)	Evomela	5		Participants
Neutrophil Engraftment	Evomela	10	Full Range 8 to 14	days
Platelet Engraftment	Evomela	17	Full Range 14 to 27	days
Treatment Related Mortality	Evomela	0		Participants
Hematologic Overall Response Rate	Evomela	22		Participants
Organ Response	Evomela	13		Participants
Participants With Peri-transplant Hospitalizations	Evomela	23		Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Enrolled	STARTED	Evomela	27
Enrolled	COMPLETED	Evomela	27
Enrolled	NOT COMPLETED	Evomela	0
6 Months Follow-up	STARTED	Evomela	27
6 Months Follow-up	COMPLETED	Evomela	24
6 Months Follow-up	NOT COMPLETED	Evomela	3
12 Month Follow-up	STARTED	Evomela	24
12 Month Follow-up	COMPLETED	Evomela	24
12 Month Follow-up	NOT COMPLETED	Evomela	0

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Evomela	25	27	25
other	Nausea	Gastrointestinal disorders	Evomela	20	27	20
other	Fatigue	General disorders	Evomela	22	27	22
serious	Cardiac arrhythmias	Cardiac disorders	Evomela	4	27	4
serious	Renal dysfunction	Renal and urinary disorders	Evomela	2	27	2
serious	Autonomic dysfunction	Nervous system disorders	Evomela	14	27	14

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Evomela	0	27
Total, other adverse events	Evomela	25	27
Total, serious adverse events	Evomela	20	27

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23091105	BACKGROUND	PubMed
37607644	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02994784

GET https://conductscience.org/api/trials/v1/NCT02994784/registered

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