Trial · NCT00298766

Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis

NCT00298766, Phase 1, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2010-08-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis. Trials, record NCT00298766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00298766

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Trial

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

Title: Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis
NCT number: NCT00298766
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 70 participants, actual
Lead sponsor: Millennium Pharmaceuticals, Inc.
Conditions: Amyloidosis
Interventions: VELCADE
First posted: 2006-03-03
Last updated: 2012-06-25
Results first posted: 2010-08-13

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose	5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts	Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts. DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity.
Primary	Subjects With Treatment Emergent Adverse Events	from first study-related procedure to 30 days after last dose of study medication	Treatment emergent adverse events observed during outcome measure time frame
Primary	Subjects With Serious Treatment Emergent Adverse Events	from first study-related procedure to 30 days after last dose of study medication	Serious treatment emergent adverse events observed during outcome measure time frame
Primary	Subjects Grade 3/4/5 Treatment Emergent Adverse Events	from first study-related procedure to 30 days after last dose of study medication	Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame. Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0.
Primary	Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination	from first study-related procedure to 30 days after last dose of study medication	Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination
Secondary	Best Confirmed Hematologic Responders	from first dose of study medication to end of study visit	Hematologic response was determined by the investigator per the response criteria for immunoglobulin light chain amyloidosis by Gertz (2005). It include Complete and Partial Responders (CR+PR). CR requires serum and urine negative for a monoclonal protein by immunofixation and free light chain ratio normal. PR requires: 1. reduction in quantitative serum M-protein by 50% if baseline value is at least 0.5 g/dL, 2. if light chain is detected in the urine (with a consistent peak and \>100 mg/ 24 hours), then 50% reduction is required, 3. if free light chain \>10 mg/dL, reduction by 50% is required.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose	5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts	Phase 1 Safety Population includes all subjects who received at least one dose of VELCADE in phase 1 dose escalation cohorts	participants with DLT	NUMBER
PRIMARY	Subjects With Treatment Emergent Adverse Events	from first study-related procedure to 30 days after last dose of study medication	Safety population	participants	NUMBER
SECONDARY	Best Confirmed Hematologic Responders	from first dose of study medication to end of study visit	Efficacy population included all treated subjects with an evaluable post baseline resposne assessment in the MTD cohorts (1.6 mg/m\^2 QW and 1.3 mg/m\^2 BIW).	participants responded	NUMBER
PRIMARY	Subjects With Serious Treatment Emergent Adverse Events	from first study-related procedure to 30 days after last dose of study medication	Safety population	participants	NUMBER
PRIMARY	Subjects Grade 3/4/5 Treatment Emergent Adverse Events	from first study-related procedure to 30 days after last dose of study medication	Safety population	participants	NUMBER
PRIMARY	Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination	from first study-related procedure to 30 days after last dose of study medication	Safety population	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Units
Maximum Tolerated Dose	Single Agent VELCADE	2	participants with DLT
Subjects With Treatment Emergent Adverse Events	Single Agent VELCADE	70	participants
Best Confirmed Hematologic Responders	Single Agent VELCADE	33	participants responded
Subjects With Serious Treatment Emergent Adverse Events	Single Agent VELCADE	25	participants
Subjects Grade 3/4/5 Treatment Emergent Adverse Events	Single Agent VELCADE	43	participants
Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination	Single Agent VELCADE	23	participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Single Agent VELCADE	70
Overall Study	COMPLETED	Single Agent VELCADE	24
Overall Study	NOT COMPLETED	Single Agent VELCADE	46

Source ClinicalTrials.gov

Adverse events100

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
other	Anaemia	Blood and lymphatic system disorders	Single Agent VELCADE	11	70
other	Leukopenia	Blood and lymphatic system disorders	Single Agent VELCADE	4	70
other	Palpitations	Cardiac disorders	Single Agent VELCADE	5	70
other	Conjunctival haemorrhage	Eye disorders	Single Agent VELCADE	5	70
other	Conjunctivitis	Eye disorders	Single Agent VELCADE	6	70
other	Dry eye	Eye disorders	Single Agent VELCADE	4	70
other	Vision blurred	Eye disorders	Single Agent VELCADE	5	70
other	Abdominal discomfort	Gastrointestinal disorders	Single Agent VELCADE	4	70
other	Abdominal distension	Gastrointestinal disorders	Single Agent VELCADE	12	70
other	Abdominal pain upper	Gastrointestinal disorders	Single Agent VELCADE	5	70

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Single Agent VELCADE
Total, other adverse events	Single Agent VELCADE	70	70
Total, serious adverse events	Single Agent VELCADE	25	70

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19498019	DERIVED	PubMed
21562045	DERIVED	PubMed
25202139	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/NCT00298766

GET https://conductscience.org/api/trials/v1/NCT00298766/events?page=2

API reference For AI assistants