Trial · NCT00097981
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
NCT00097981, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2008-11-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma. Trials, record NCT00097981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00097981
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
- NCT number
- NCT00097981
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 225 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Multiple Myeloma
- Interventions
- Thalidomide, Dexamethasone, DOXIL
- First posted
- 2004-12-02
- Last updated
- 2017-04-07
- Results first posted
- 2008-11-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate: Number of Participants Who Achieved a Complete Response | From Cycle 2 until 28 days following completion of treatment | Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2. |
| Secondary | Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | From Cycle 2 until 28 days following completion of treatment | Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein. |
| Secondary | Time to 1st Response | From Cycle 2 until 28 days following completion of treatment | Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein. |
| Secondary | Time to Progression | From randomization until death or as assessed up to 2 years post last participant last treatment visit | Time to progression is the interval between the date of randomization until disease progression or death due to progression. |
| Secondary | Overall Survival: Number of Participants Died Due to Any Cause | From randomization until death or as assessed up to 2 years post last participant last treatment visit | |
| Secondary | Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow) | From randomization until death or as assessed up to 2 years post last participant last treatment visit | |
| Secondary | Engraftment: Number of Participants Who Underwent Engraftment | From randomization until death or as assessed up to 2 years post last participant last treatment visit | Engraftment is the process of transplanted stem cells reproducing new cells. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response Rate: Number of Participants Who Achieved a Complete Response | From Cycle 2 until 28 days following completion of treatment | Intent-to-treat: Participants who were randomized to receive the treatment. | Participants | NUMBER |
| SECONDARY | Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | From Cycle 2 until 28 days following completion of treatment | Intent-to-treat: Participants who were randomized to receive the treatment. | Participants | NUMBER |
| SECONDARY | Time to 1st Response | From Cycle 2 until 28 days following completion of treatment | Intent-to-treat: Participants who were randomized to receive the treatment. | Days | MEDIAN |
| SECONDARY | Time to Progression | From randomization until death or as assessed up to 2 years post last participant last treatment visit | Intent-to-treat: Participants who were randomized to receive the treatment. | Days | MEDIAN |
| SECONDARY | Overall Survival: Number of Participants Died Due to Any Cause | From randomization until death or as assessed up to 2 years post last participant last treatment visit | Intent-to-treat: Participants who were randomized to receive the treatment. | Participants | NUMBER |
| SECONDARY | Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow) | From randomization until death or as assessed up to 2 years post last participant last treatment visit | Intent-to-treat: Participants who were randomized to receive the treatment. | Participants | NUMBER |
| SECONDARY | Engraftment: Number of Participants Who Underwent Engraftment | From randomization until death or as assessed up to 2 years post last participant last treatment visit | Intent-to-treat: Participants who were randomized to receive the treatment and who underwent transplantation. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate: Number of Participants Who Achieved a Complete Response | Thalidomide + Dexamethasone | 5 | Participants | ||
| Complete Response Rate: Number of Participants Who Achieved a Complete Response | DOXIL + Thalidomide + Dexamethasone | 8 | Participants | ||
| Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | Thalidomide + Dexamethasone | 81 | Participants | ||
| Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | DOXIL + Thalidomide + Dexamethasone | 76 | Participants | ||
| Time to 1st Response | Thalidomide + Dexamethasone | 44 | 95% Confidence Interval 37 to 58 | Days | |
| Time to 1st Response | DOXIL + Thalidomide + Dexamethasone | 58 | 95% Confidence Interval 44 to 60 | Days | |
| Time to Progression | Thalidomide + Dexamethasone | 584 | 95% Confidence Interval 347 to NA | Days | |
| Time to Progression | DOXIL + Thalidomide + Dexamethasone | 408 | 95% Confidence Interval 350 to 597 | Days | |
| Overall Survival: Number of Participants Died Due to Any Cause | Thalidomide + Dexamethasone | 21 | Participants | ||
| Overall Survival: Number of Participants Died Due to Any Cause | DOXIL + Thalidomide + Dexamethasone | 22 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thalidomide + Dexamethasone | 113 | |
| Overall Study | STARTED | DOXIL + Thalidomide + Dexamethasone | 112 | |
| Overall Study | Received Study Medication | Thalidomide + Dexamethasone | 110 | |
| Overall Study | Received Study Medication | DOXIL + Thalidomide + Dexamethasone | 106 | |
| Overall Study | COMPLETED | Thalidomide + Dexamethasone | 7 | |
| Overall Study | COMPLETED | DOXIL + Thalidomide + Dexamethasone | 12 | |
| Overall Study | NOT COMPLETED | Thalidomide + Dexamethasone | 106 | |
| Overall Study | NOT COMPLETED | DOXIL + Thalidomide + Dexamethasone | 100 |
Source ClinicalTrials.gov
Adverse events400
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 | Thalidomide + Dexamethasone | 21 | 110 | |
| other | Anaemia | Blood and lymphatic system disorders | DOXIL + Thalidomide + Dexamethasone | 31 | 106 | |
| other | Leukopenia | Blood and lymphatic system disorders | Thalidomide + Dexamethasone | 6 | 110 | |
| other | Leukopenia | Blood and lymphatic system disorders | DOXIL + Thalidomide + Dexamethasone | 2 | 106 | |
| other | Neutropenia | Blood and lymphatic system disorders | Thalidomide + Dexamethasone | 4 | 110 | |
| other | Neutropenia | Blood and lymphatic system disorders | DOXIL + Thalidomide + Dexamethasone | 21 | 106 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Thalidomide + Dexamethasone | 6 | 110 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | DOXIL + Thalidomide + Dexamethasone | 1 | 106 | |
| other | Cushingoid | Endocrine disorders | Thalidomide + Dexamethasone | 5 | 110 | |
| other | Cushingoid | Endocrine disorders | DOXIL + Thalidomide + Dexamethasone | 7 | 106 |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thalidomide + Dexamethasone | ||
| Total, all-cause mortality | DOXIL + Thalidomide + Dexamethasone | ||
| Total, other adverse events | Thalidomide + Dexamethasone | 110 | 110 |
| Total, other adverse events | DOXIL + Thalidomide + Dexamethasone | 104 | 106 |
| Total, serious adverse events | Thalidomide + Dexamethasone | 48 | 110 |
| Total, serious adverse events | DOXIL + Thalidomide + Dexamethasone | 53 | 106 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thalidomide + Dexamethasone vs DOXIL + Thalidomide + Dexamethasone: Engraftment: Number of Participants Who Underwent Engraftment | Trial comparisons |
| Thalidomide + Dexamethasone vs DOXIL + Thalidomide + Dexamethasone: Overall Survival: Number of Participants Died Due to Any Cause | Trial comparisons |
| Thalidomide + Dexamethasone vs DOXIL + Thalidomide + Dexamethasone: Complete Response Rate: Number of Participants Who Achieved a Complete Response | Trial comparisons |
| Thalidomide + Dexamethasone vs DOXIL + Thalidomide + Dexamethasone: Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) | Trial comparisons |
| Thalidomide + Dexamethasone vs DOXIL + Thalidomide + Dexamethasone: Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow) | Trial comparisons |
| Thalidomide + Dexamethasone vs DOXIL + Thalidomide + Dexamethasone: 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/NCT00097981
GET https://conductscience.org/api/trials/v1/NCT00097981/events?page=2