Trial · NCT00432458
Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma
NCT00432458, Phase 3, Completed, Mayo Clinic; results first posted 2012-07-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma. Trials, record NCT00432458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00432458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma
- NCT number
- NCT00432458
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 68 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- Thalidomide, zoledronic acid
- First posted
- 2007-02-07
- Last updated
- 2012-07-04
- Results first posted
- 2012-07-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Disease Progression (TTP) | randomization to progression (up to 5 years) | Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated. |
| Secondary | 12-month Progression-free Survival (PFS) | 12 months | PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of randomization. |
| Secondary | Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment | 12 months | Response is defined as follows: * CR: Complete disappearance of M-protein from serum \& urine on immunofixation, \<5% plasma cells in bone marrow (BM) * VGPR: \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * PR: \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels |
| Secondary | Duration of Response (Complete Response, Partial Response, and Very Good Partial Response) | time from start of response to progression (up to 5 years) | Duration of response (DOR) is defined as the time from first documentation of response (CR, VGPR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method |
| Secondary | Time to Subsequent Treatment | time from end of treatment to subsequent treatment (up to 5 years) | Time to subsequent treatment (TTS) was defined as time from end of active (protocol) treatment to the start of subsequent treatment for participants with progressive disease. The median TTS with 95% CI was estimated using the Kaplan Meier method |
| Secondary | Time to Treatment Failure | time from randomization to treatment failure (up to 5 years) | Time to treatment failure (TTF) was defined as the time from randomization to the date at which the patient was removed from (protocol) treatment due to disease progression, unacceptable toxicity, participant refusal or death. The median TTF with 95% CI was estimated using the Kaplan Meier method |
| Secondary | Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events | During treatment (up to 5 years) | Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 2. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death |
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 | Time to Disease Progression (TTP) | randomization to progression (up to 5 years) | Time to disease progression was analyzed on all randomized participants on an intent to treat basis. | years | MEDIAN |
| SECONDARY | 12-month Progression-free Survival (PFS) | 12 months | participants | NUMBER | |
| SECONDARY | Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment | 12 months | participants | NUMBER | |
| SECONDARY | Duration of Response (Complete Response, Partial Response, and Very Good Partial Response) | time from start of response to progression (up to 5 years) | Participants who achieved a confirmed response (CR, VGPR, or PR) as described above were analyzed. | years | MEDIAN |
| SECONDARY | Time to Subsequent Treatment | time from end of treatment to subsequent treatment (up to 5 years) | This data was not (and will never be) analyzed as it was not submitted consistently across all participants. | years | MEDIAN |
| SECONDARY | Time to Treatment Failure | time from randomization to treatment failure (up to 5 years) | months | MEDIAN | |
| SECONDARY | Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events | During treatment (up to 5 years) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Disease Progression (TTP) | Arm I: Thal/ZLD | 2.4 | 95% Confidence Interval 1.4 to 3.6 | years | |
| Time to Disease Progression (TTP) | Arm II: ZLD | 1.2 | 95% Confidence Interval 0.7 to 2.5 | years | |
| 12-month Progression-free Survival (PFS) | Arm I: Thal/ZLD | 30 | participants | ||
| 12-month Progression-free Survival (PFS) | Arm II: ZLD | 18 | participants | ||
Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment | Arm I: Thal/ZLD | 13 | participants | ||
Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment | Arm II: ZLD | 0 | participants | ||
| Duration of Response (Complete Response, Partial Response, and Very Good Partial Response) | Arm I: Thal/ZLD | 3.3 | 95% Confidence Interval 1.1 to NA | years | |
| Time to Treatment Failure | Arm I: Thal/ZLD | 16.5 | 95% Confidence Interval 9.5 to 27.6 | months | |
| Time to Treatment Failure | Arm II: ZLD | 11.1 | 95% Confidence Interval 8.4 to 16.7 | months | |
| Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events | Arm I: Thal/ZLD | 17 | participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Thal/ZLD | 35 | |
| Overall Study | STARTED | Arm II: ZLD | 33 | |
| Overall Study | COMPLETED | Arm I: Thal/ZLD | 30 | |
| Overall Study | COMPLETED | Arm II: ZLD | 32 | |
| Overall Study | NOT COMPLETED | Arm I: Thal/ZLD | 5 | |
| Overall Study | NOT COMPLETED | Arm II: ZLD | 1 |
Source ClinicalTrials.gov
Adverse events114
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 | Anemia | Blood and lymphatic system disorders | Arm I: Thal/ZLD | 2 | 35 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Arm II: ZLD | 1 | 33 | 5 |
| other | Cardiovascular | Cardiac disorders | Arm I: Thal/ZLD | 1 | 35 | 1 |
| other | Cardiovascular | Cardiac disorders | Arm II: ZLD | 0 | 33 | 0 |
| other | Ischemia/Infarction | Cardiac disorders | Arm I: Thal/ZLD | 2 | 35 | 2 |
| other | Ischemia/Infarction | Cardiac disorders | Arm II: ZLD | 0 | 33 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Arm I: Thal/ZLD | 2 | 35 | 3 |
| other | Sinus bradycardia | Cardiac disorders | Arm II: ZLD | 0 | 33 | 0 |
| other | Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | Cardiac disorders | Arm I: Thal/ZLD | 2 | 35 | 2 |
| other | Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | Cardiac disorders | Arm II: ZLD | 0 | 33 | 0 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Thal/ZLD | ||
| Total, all-cause mortality | Arm II: ZLD | ||
| Total, other adverse events | Arm I: Thal/ZLD | 35 | 35 |
| Total, other adverse events | Arm II: ZLD | 28 | 33 |
| Total, serious adverse events | Arm I: Thal/ZLD | 3 | 35 |
| Total, serious adverse events | Arm II: ZLD | 1 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22902362 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I: Thal/ZLD vs Arm II: ZLD: Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events | Trial comparisons |
Arm I: Thal/ZLD vs Arm II: ZLD: Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment | Trial comparisons |
| Arm I: Thal/ZLD vs Arm II: ZLD: 12-month Progression-free Survival (PFS) | Trial comparisons |
| Arm I: Thal/ZLD vs Arm II: ZLD: 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/NCT00432458
GET https://conductscience.org/api/trials/v1/NCT00432458/events?page=2