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Monoclonal Antibodies

PD-1 Blockade + Dendritic Cell Fusion Vaccine + CT-011 for Multiple Myeloma

Phase 2
Waitlist Available
Led By David Avigan, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing the safety of CT-011 and the combination of the Dendritic cell fusion vaccine and CT-011 after ASCT in patients with multiple myeloma. They are also testing to see if the combination is more successful in preventing or delaying the disease from coming back, compared to treatment with ASCT alone.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
First Stage: To explore immunological response to CT-011 in the post transplant period.
Second Stage: To determine if cellular immunity is induced by treatment with monoclonal antibody CT-011 and DC/myeloma fusion cells in conjunction with stem cell transplant.
Secondary outcome measures
First Stage: To assess the toxicity associated with treating multiple myeloma patients with CT-011 in the post- autologous transplant setting.
Second Stage: To assess the toxicity associated with treating multiple myeloma patients with the combination with DC/myeloma fusion vaccine following autologous transplant.
Second Stage: To correlate levels of circulating activated and regulatory T cells with immunologic response
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Group 1Active Control1 Intervention
Monoclonal antibody CT-011 will be given 1-3 months following autologous transplant. 3 doses will be given at 6 week intervals.
Group II: Group 2Active Control2 Interventions
Vaccination with DC/myeloma fusion cells will be given 1-3 months following autologous transplant. Vaccination will be given at 6 weeks intervals. The monoclonal antibody CT-011 will be given 1 week following each vaccination. 3 doses of CT-011 will be given at 6 week intervals.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
861 Previous Clinical Trials
227,159 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,609 Previous Clinical Trials
11,470,292 Total Patients Enrolled
11 Trials studying Multiple Myeloma
475 Patients Enrolled for Multiple Myeloma
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,301 Total Patients Enrolled
13 Trials studying Multiple Myeloma
1,095 Patients Enrolled for Multiple Myeloma

Media Library

CT-011 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01067287 — Phase 2
Multiple Myeloma Research Study Groups: Group 1, Group 2
Multiple Myeloma Clinical Trial 2023: CT-011 Highlights & Side Effects. Trial Name: NCT01067287 — Phase 2
CT-011 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01067287 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the research team recruiting for this clinical experiment?

"This trial is no longer accepting participants. It was first posted on March 1st 2010, and the most recent amendment to it took place on September 5th 2022. Currently there are 807 studies seeking patients with multiple myeloma and one study searching for Group 2 subjects."

Answered by AI

Is Group 2 a viable option for patients with regards to safety?

"Group 2's safety was evaluated and assessed as a score of 2, given that there is existing data validating its security but none currently affirming its efficacy."

Answered by AI

Are there any opportunities for participants to join this experiment?

"Unfortunately, this medical study is no longer enrolling patients. Initially posted on March 1st 2010 and last edited September 5th 2022, any prospective participants are encouraged to check out the 807 studies actively searching for individuals with multiple myeloma or the single trial looking for Group 2 applicants."

Answered by AI

Could you provide me with an overview of the other experiments carried out in relation to Group 2?

"At the current moment, only 1 research project concerning Group 2 is active with 0 Phase 3 trials. These studies are mainly held in Boston but also span to other locations."

Answered by AI
~2 spots leftby Apr 2025