Trial · NCT00083382
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
NCT00083382, Phase 2, Completed, University of Arkansas; results first posted 2015-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide. Trials, record NCT00083382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00083382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide
- NCT number
- NCT00083382
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- University of Arkansas
- Conditions
- Multiple Myeloma
- Interventions
- Pamidronate, Thalidomide, Zometa
- First posted
- 2004-05-24
- Last updated
- 2015-06-24
- Results first posted
- 2015-06-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Response | 2 years | Best response to study treatment as defined by protocol-specific response criteria: Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (\>20%) with \<1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by \> 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to \<5%; Decrease in Bence-Jones proteinuria by \>90%; No new lytic bone lesions or soft tissue plasmacytoma. Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Response | 2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Response | Thalidomide + Bisphosphonate | Treatment Failure/Progressive Disease | 56 | participants | |
| Best Response | Thalidomide + Bisphosphonate | Partial Response | 17 | participants | |
| Best Response | Thalidomide + Bisphosphonate | Complete Response | 10 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thalidomide + Bisphosphonate | 83 | |
| Overall Study | COMPLETED | Thalidomide + Bisphosphonate | 83 | |
| Overall Study | NOT COMPLETED | Thalidomide + Bisphosphonate | 0 |
Source ClinicalTrials.gov
Adverse events137
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 | Grade 1 Allergic rhinitis | Immune system disorders | Thalidomide + Bisphosphonate | 7 | 83 | |
| other | Grade 1 Anemia | Blood and lymphatic system disorders | Thalidomide + Bisphosphonate | 25 | 83 | |
| other | Grade 2 Anemia | Blood and lymphatic system disorders | Thalidomide + Bisphosphonate | 8 | 83 | |
| other | Grade 1 Neutropenia/granulocytopenia | Blood and lymphatic system disorders | Thalidomide + Bisphosphonate | 10 | 83 | |
| other | Grade 2 Neutropenia/granulocytopenia | Blood and lymphatic system disorders | Thalidomide + Bisphosphonate | 17 | 83 | |
| other | Grade 1 Thrombocytopenia | Blood and lymphatic system disorders | Thalidomide + Bisphosphonate | 17 | 83 | |
| other | Grade 2 Thrombocytopenia | Blood and lymphatic system disorders | Thalidomide + Bisphosphonate | 5 | 83 | |
| other | Grade 3 Thrombocytopenia | Blood and lymphatic system disorders | Thalidomide + Bisphosphonate | 5 | 83 | |
| other | Grade 2 Leukopenia | Blood and lymphatic system disorders | Thalidomide + Bisphosphonate | 20 | 83 | |
| other | Grade 1 Arrhythmia, NOS | Cardiac disorders | Thalidomide + Bisphosphonate | 9 | 83 |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thalidomide + Bisphosphonate | ||
| Total, other adverse events | Thalidomide + Bisphosphonate | 83 | 83 |
| Total, serious adverse events | Thalidomide + Bisphosphonate | 16 | 83 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18669874 | DERIVED |
Source 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.
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/NCT00083382
GET https://conductscience.org/api/trials/v1/NCT00083382/events?page=2