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NCT01067287 · ClinicalTrials.gov registry record · Phase 2
Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
A Phase 2 study of Multiple Myeloma, sponsored by Beth Israel Deaconess Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 3
- Study locations
NCT01067287: Active Phase 2 study of Multiple Myeloma, sponsored by Beth Israel Deaconess Medical Center.
NCT01067287 is a Phase 2 study of Multiple Myeloma that is active but no longer recruiting, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 35 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01067287, a Phase 2 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Beth Israel Deaconess Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this research study is to determine the safety of CT-011 alone, as well as the combination of the Dendritic cell fusion vaccine and CT-011, after autologous stem cell transplantation (ASCT). We are also trying to find out what effect the combination has on the disease, including if it is more successful in preventing or delaying the disease from coming back, compared to treatment with autologous transplantation alone. ASCT is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer in the body. CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug given by infusion into a vein and are known to target specific cells (in this case, cells in the immune system). The dendritic cell fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines are being studied to see if they can fight cancers that are already in the body.
Primary Outcome
Immune response will be measured by assessing percentage of T cells that express IFNγ following ex-vivo exposure to tumor lysate, as determined by the ratio of the maximum IFNγ expression to the baseline level pre-transplantation. A threshold response of a 10 fold increase in T cells expressing IFNγ will be considered significant. In the pilot phase, summary statistics (mean, median, range, standard error) will be used to report immunologic response on the entire patient cohort. In order to inc
Conditions Studied
Interventions
- DRUG CT-011
- BIOLOGICAL Dendritic Cell Fusion Vaccine
Study Locations (3)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Other
- Rambam Medical Center - Haifa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-03 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT01067287 still lists
NCT01067287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which CT-011 is the first listed.
NCT01067287 reports a single indexed study location in Massachusetts, Other.
Frequently Asked Questions
What is clinical trial NCT01067287 about?
NCT01067287 is a clinical study titled "Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation". The purpose of this research study is to determine the safety of CT-011 alone, as well as the combination of the Dendritic cell fusion vaccine and CT-011, after autologous stem cell transplantation (ASCT). We are also trying to find out what effect the combination has on the disease, including if it...
What is the current status of trial NCT01067287?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2010-03. Estimated completion is 2025-12.
What conditions does trial NCT01067287 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT01067287?
The interventions under investigation include: CT-011 (DRUG), Dendritic Cell Fusion Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01067287?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01067287 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01067287's enrollment target sits among peer trials
35 315th of 438 higher than 120 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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