Monoclonal Antibodies

Group 1 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

Patients with multiple myeloma who are potential candidates for high doses chemotherapy with stem cell rescue

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up3 years

Awards & highlights

No Placebo-Only Group

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have multiple myeloma and may need high-dose chemotherapy with stem cell rescue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

United States Department of DefenseFED

814 Previous Clinical Trials

216,102 Total Patients Enrolled

Brigham and Women's HospitalOTHER

1,545 Previous Clinical Trials

11,380,040 Total Patients Enrolled

11 Trials studying Multiple Myeloma

475 Patients Enrolled for Multiple Myeloma

Beth Israel Deaconess Medical CenterLead Sponsor

822 Previous Clinical Trials

6,994,060 Total Patients Enrolled

13 Trials studying Multiple Myeloma

1,027 Patients Enrolled for Multiple Myeloma

Dana-Farber Cancer InstituteOTHER

1,047 Previous Clinical Trials

764,525 Total Patients Enrolled

51 Trials studying Multiple Myeloma

34,287 Patients Enrolled for Multiple Myeloma

Rambam Health Care CampusOTHER

501 Previous Clinical Trials

340,611 Total Patients Enrolled

1 Trials studying Multiple Myeloma

45 Patients Enrolled for Multiple Myeloma

Gateway for Cancer ResearchOTHER

41 Previous Clinical Trials

2,374 Total Patients Enrolled

2 Trials studying Multiple Myeloma

226 Patients Enrolled for Multiple Myeloma

David Avigan, MDPrincipal Investigator

Beth Israel Deaconess Medical Center

14 Previous Clinical Trials

424 Total Patients Enrolled

2 Trials studying Multiple Myeloma

63 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

Recent research and studies

clinicaltrials.govStudy

Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation

David Avigan 2010. "Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01067287.