Trial · NCT01245673
Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma
NCT01245673, Phase 2, Completed, University of Pennsylvania; results first posted 2020-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma. Trials, record NCT01245673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01245673
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma
- NCT number
- NCT01245673
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Myeloma
- Interventions
- Prevnar- Pneumococcal Conjugate Vaccine (PCV), Activated/costimulated autologous T-cell, Revlamid® (Lenalidomide), MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC)
- First posted
- 2010-11-22
- Last updated
- 2020-04-06
- Results first posted
- 2020-03-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Myeloma Endpoint | Between day 100 and 180 post transplant | To determine whether lenalidomide maintenance plus the late booster immunizations leads to improved myeloma clinical responses between day 180 and day 100 post-transplant. |
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 | Primary Myeloma Endpoint | Between day 100 and 180 post transplant | Subjects that reached D100 and D180 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Myeloma Endpoint | Prevnar, T Cells, Lenalidomide, MAGE A-3 | Subjects in CR D100 and D180 | 4 | Participants | |
| Primary Myeloma Endpoint | Prevnar, T Cells, Lenalidomide, MAGE A-3 | Subjects in sCR D100 and 180 | 1 | Participants | |
| Primary Myeloma Endpoint | Prevnar, T Cells, Lenalidomide, MAGE A-3 | Subjects in VGPR D100 and D180 | 1 | Participants | |
| Primary Myeloma Endpoint | Prevnar, T Cells, Lenalidomide, MAGE A-3 | Subjects in PR D100 and D180 | 5 | Participants | |
| Primary Myeloma Endpoint | Prevnar, T Cells, Lenalidomide, MAGE A-3 | Subjects with SD at D+100 and 180 | 3 | Participants | |
| Primary Myeloma Endpoint | Prevnar, T Cells, Lenalidomide, MAGE A-3 | Subjects with improved response at D100 and D180 | 6 | Participants | |
| Primary Myeloma Endpoint | Prevnar, T Cells, Lenalidomide, MAGE A-3 | Subjects with poorer response at D100 and D180 | 4 | Participants | |
| Primary Myeloma Endpoint | Prevnar, T Cells, Lenalidomide, MAGE A-3 | Subjects with no disease response reported | 2 | Participants |
Source ClinicalTrials.gov
Participant flow19
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrollment | STARTED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 28 | |
| Enrollment | COMPLETED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 27 | |
| Enrollment | NOT COMPLETED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 1 | |
| Pre Transplant Vaccinations | STARTED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 27 | |
| Pre Transplant Vaccinations | Pre Transplant Vaccinations 1-3 | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 27 | |
| Pre Transplant Vaccinations | COMPLETED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 27 | |
| Pre Transplant Vaccinations | NOT COMPLETED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 0 | |
| Activated/Costimulated Autologous T Cell | STARTED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 27 | |
| Activated/Costimulated Autologous T Cell | COMPLETED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 27 | |
| Activated/Costimulated Autologous T Cell | NOT COMPLETED | MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide, | 0 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 participant flowAdverse events46
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 | Anorexia | Metabolism and nutrition disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 9 | 27 | 14 |
| other | Chills | General disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 5 | 27 | 7 |
| other | Diarrhea | Gastrointestinal disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 4 | 27 | 5 |
| other | Fatigue | General disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 7 | 27 | 7 |
| other | Fever | General disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 10 | 27 | 16 |
| other | Flu-like symptoms | Infections and infestations | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 2 | 27 | 3 |
| other | Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 2 | 27 | 2 |
| other | Headache | Nervous system disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 8 | 27 | 10 |
| other | Increased eosinophil | Blood and lymphatic system disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 2 | 27 | 3 |
| other | Induration | Skin and subcutaneous tissue disorders | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 3 | 27 | 5 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 0 | 27 |
| Total, other adverse events | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 27 | 27 |
| Total, serious adverse events | Prevnar, T Cells, Lenalidomide, MAGE A-3 | 9 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24520093 | 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/NCT01245673
GET https://conductscience.org/api/trials/v1/NCT01245673/events?page=2