Trial · NCT01548573
Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment
NCT01548573, Phase 2, Terminated, University of Iowa; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment. Trials, record NCT01548573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01548573
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tandem Auto Transplantation in Myeloma Patients With <12 Months of Prior Treatment
- NCT number
- NCT01548573
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- University of Iowa
- Conditions
- Multiple Myeloma
- Interventions
- Dexamethasone, Tandem autologous stem cell transplant, Cisplatin, Doxorubicin, Cyclophosphamide, Etoposide, Bortezomib, Thalidomide, Melphalan
- First posted
- 2012-03-08
- Last updated
- 2017-06-14
- Results first posted
- 2017-06-14
- Limitations and caveats
- Enrollment halted prematurely. Study met stopping rules. Outcomes will not be tracked and published
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) | 8 years | To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis. |
| Primary | Identification of Drug Resistant Genes | 5 years | To determine whether repeated bone marrow samples analyzed for gene expression profiling (GEP) can identify genes related to drug resistance in myeloma. The drug resistant genes or the gene products might then be targeted specifically to eradicate myeloma cells surviving tandem transplantation. |
| Secondary | Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens. | 2 years | To determine whether bortezomib, thalidomide and dexamethasone with transplant 1 and velcade/gemcitabine with transplant 2 can be safely incorporated into well-tested pre-transplant regimens of high-dose melphalan and carmustine/melphalan in doses equivalent to the BEAM(BCNU, etoposide, arabinoside, melphalan)regimen. Treatment-related toxicities will be compared to those reported in the literature using similar intensive approaches. |
| Secondary | Overall Survival | 10 years | To determine the median overall survival based on an intent-to-treat analysis, which should exceed 10 years, based on the projected 10-year survival of Total Therapy III, keeping in mind that participants are included in this protocol with up to 12 months of prior therapy. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-Free Survival (EFS) | 8 years | Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 1 were not collected. | ||
| PRIMARY | Identification of Drug Resistant Genes | 5 years | Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 2 were not collected. | ||
| SECONDARY | Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens. | 2 years | Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 3 were not collected. | ||
| SECONDARY | Overall Survival | 10 years | Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 4 were not collected. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-Free Survival (EFS) | Tandem Autologous Stem Cell Transplant | 0 | |||
| Identification of Drug Resistant Genes | Tandem Transplant in MM <12 Mos of Prior Treatment | 0 | |||
| Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens. | Tandem Transplant in MM <12 Mos of Prior Treatment | 0 | |||
| Overall Survival | Tandem Transplant in MM <12 Mos of Prior Treatment | 0 |
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 | Tandem Transplant in MM <12 Mos of Prior Treatment | 19 | |
| Overall Study | COMPLETED | Tandem Transplant in MM <12 Mos of Prior Treatment | 14 | |
| Overall Study | NOT COMPLETED | Tandem Transplant in MM <12 Mos of Prior Treatment | 5 |
Source ClinicalTrials.gov
Adverse events252
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 | Abdominal Pain | Gastrointestinal disorders | Tandem Transplant in MM <12 Mos of Prior Treatment | 1 | 19 | 1 |
| other | Abdominal Pain/discomfort LLQ | Gastrointestinal disorders | Tandem Transplant in MM <12 Mos of Prior Treatment | 1 | 19 | 1 |
| other | Abdominal Pain/discomfort RUQ | Gastrointestinal disorders | Tandem Transplant in MM <12 Mos of Prior Treatment | 1 | 19 | 1 |
| other | Activated PTT prolonged | Investigations | Tandem Transplant in MM <12 Mos of Prior Treatment | 1 | 19 | 2 |
| other | Acute kidney injury | Renal and urinary disorders | Tandem Transplant in MM <12 Mos of Prior Treatment | 1 | 19 | 1 |
| other | Adult Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | Tandem Transplant in MM <12 Mos of Prior Treatment | 2 | 19 | 2 |
| other | Akathisia (restless feet) | Nervous system disorders | Tandem Transplant in MM <12 Mos of Prior Treatment | 1 | 19 | 1 |
| other | Alanine aminotransferase increased | Investigations | Tandem Transplant in MM <12 Mos of Prior Treatment | 4 | 19 | 4 |
| other | Allergic reaction during PBSC Collection | Investigations | Tandem Transplant in MM <12 Mos of Prior Treatment | 1 | 19 | 1 |
| other | ALT increased | Investigations | Tandem Transplant in MM <12 Mos of Prior Treatment | 5 | 19 | 6 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tandem Transplant in MM <12 Mos of Prior Treatment | 3 | 19 |
| Total, other adverse events | Tandem Transplant in MM <12 Mos of Prior Treatment | 19 | 19 |
| Total, serious adverse events | Tandem Transplant in MM <12 Mos of Prior Treatment | 13 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| R01CA115399 | Gene expression profiling vs MRD assessment in Myeloma | TRICOT, GUIDO J. | UNIVERSITY OF IOWA | NATIONAL CANCER INSTITUTE | 2006 to 2011 |
Source NIH RePORTER
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/NCT01548573
GET https://conductscience.org/api/trials/v1/NCT01548573/events?page=2