Trial · NCT00103506
Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
NCT00103506, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2015-05-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma. Trials, record NCT00103506. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103506
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
- NCT number
- NCT00103506
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 646 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Multiple Myeloma
- Interventions
- Bortezomib (VELCADE), Bortezomib (VELCADE), Doxorubicin hydrochloride (DOXIL/CAELYX)
- First posted
- 2005-02-10
- Last updated
- 2015-10-19
- Other registries' IDs
- eudract:2004-001842-34
- Results first posted
- 2015-05-25
- Limitations and caveats
- Study stopped in terms of primary endpoint based on its results at planned interim analysis (28 Apr 2006). However, Long-term follow-up for survival continued until 16 May 2014.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression (TTP) | Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006]) | Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of \>=25% from lowest level in Serum M-component or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]); Urine M component or (the absolute increase must be \>=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase \>10 mg/dL. Bone marrow plasma cell percentage \>=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date. |
| Secondary | Overall Survival | Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014) | The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006) | A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression (TTP) | Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006]) | Intent-to-treat (ITT) included all the randomized participants. | Months | MEDIAN |
| SECONDARY | Overall Survival | Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014) | months | MEDIAN | |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006) | Safety population included all the participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression (TTP) | Velcade (Bortezomib) Monotherapy | 6.5 | 95% Confidence Interval 5.6 to 7.1 | Months | |
| Time to Progression (TTP) | Doxil/Caelyx Plus Velcade (Bortezomib) | 9.3 | 95% Confidence Interval 8.2 to 11.1 | Months | |
| Overall Survival | Velcade (Bortezomib) Monotherapy | 30.8 | 95% Confidence Interval 25.2 to 36.5 | months | |
| Overall Survival | Doxil/Caelyx Plus Velcade (Bortezomib) | 33.0 | 95% Confidence Interval 28.9 to 37.1 | months | |
| Number of Participants With Serious Adverse Events (SAEs) | Velcade (Bortezomib) Monotherapy | 105 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Doxil/Caelyx Plus Velcade (Bortezomib) | 120 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Velcade (Bortezomib) Monotherapy | 322 | |
| Overall Study | STARTED | Doxil/Caelyx Plus Velcade (Bortezomib) | 324 | |
| Overall Study | COMPLETED | Velcade (Bortezomib) Monotherapy | 0 | |
| Overall Study | COMPLETED | Doxil/Caelyx Plus Velcade (Bortezomib) | 0 | |
| Overall Study | NOT COMPLETED | Velcade (Bortezomib) Monotherapy | 322 | |
| Overall Study | NOT COMPLETED | Doxil/Caelyx Plus Velcade (Bortezomib) | 324 |
Source ClinicalTrials.gov
Adverse events524
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 | Anaemia | Blood and lymphatic system disorders | Velcade (Bortezomib) Monotherapy | 67 | 318 | |
| other | Anaemia | Blood and lymphatic system disorders | Doxil/Caelyx Plus Velcade (Bortezomib) | 80 | 318 | |
| other | Leukopenia | Blood and lymphatic system disorders | Velcade (Bortezomib) Monotherapy | 23 | 318 | |
| other | Leukopenia | Blood and lymphatic system disorders | Doxil/Caelyx Plus Velcade (Bortezomib) | 28 | 318 | |
| other | Neutropenia | Blood and lymphatic system disorders | Velcade (Bortezomib) Monotherapy | 71 | 318 | |
| other | Neutropenia | Blood and lymphatic system disorders | Doxil/Caelyx Plus Velcade (Bortezomib) | 113 | 318 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Velcade (Bortezomib) Monotherapy | 89 | 318 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Doxil/Caelyx Plus Velcade (Bortezomib) | 104 | 318 | |
| other | Conjunctivitis | Eye disorders | Velcade (Bortezomib) Monotherapy | 17 | 318 | |
| other | Conjunctivitis | Eye disorders | Doxil/Caelyx Plus Velcade (Bortezomib) | 24 | 318 |
1 to 10 of 524Source ClinicalTrials.gov
See all 524 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Velcade (Bortezomib) Monotherapy | ||
| Total, all-cause mortality | Doxil/Caelyx Plus Velcade (Bortezomib) | ||
| Total, other adverse events | Velcade (Bortezomib) Monotherapy | 299 | 318 |
| Total, other adverse events | Doxil/Caelyx Plus Velcade (Bortezomib) | 313 | 318 |
| Total, serious adverse events | Velcade (Bortezomib) Monotherapy | 105 | 318 |
| Total, serious adverse events | Doxil/Caelyx Plus Velcade (Bortezomib) | 120 | 318 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Velcade (Bortezomib) Monotherapy vs Doxil/Caelyx Plus Velcade (Bortezomib): Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
| Velcade (Bortezomib) Monotherapy vs Doxil/Caelyx Plus Velcade (Bortezomib): serious adverse events | Trial comparisons |
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.
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/NCT00103506
GET https://conductscience.org/api/trials/v1/NCT00103506/events?page=2