Study on Using PD-1 Blockade with Dendritic Cell/Myeloma Vaccines After Stem Cell Transplant for Multiple Myeloma

Sponsor: Beth Israel Deaconess Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01067287

Provider View

This clinical trial is exploring the safety and effectiveness of a new treatment approach for multiple myeloma, combining a drug called CT-011 with a special vaccine after a stem cell transplant. The study aims to see if this combination can better prevent or delay the return of the disease compared to the transplant alone.

Patient Parameters

Program Overview

The study is testing a new treatment for multiple myeloma, a type of blood cancer. It involves using a drug called CT-011, which is an investigational antibody that targets immune cells, and a dendritic cell fusion vaccine, which aims to help the immune system fight cancer. These treatments are given after a standard procedure called autologous stem cell transplantation (ASCT), which is used to reduce cancer in the body. The goal is to see if this combination is safe and if it can prevent or delay the cancer from coming back better than the transplant alone.

Description

This study involves two groups of participants:

  • Group 1: Participants will receive three doses of CT-011, starting one to three months after their stem cell transplant. The doses are given six weeks apart.
  • Group 2: Participants will receive the same three doses of CT-011 as Group 1, but they will also receive a dendritic cell fusion vaccine one week after each CT-011 dose.

All participants will undergo several procedures:

  1. Initial Therapy: Standard treatment to reduce multiple myeloma cells.
  2. Pre-Transplant Tests: Physical exam, medical history, blood tests, bone marrow sample, and a skin test.
  3. Stem Cell Collection: Stem cells are collected from the blood and stored for the transplant.
  4. Stem Cell Transplant: High-dose chemotherapy followed by the stem cell transplant.
  5. Post-Transplant Tests: Additional tests to determine eligibility for CT-011 treatment.

If eligible, participants will receive CT-011 infusions every six weeks, with regular check-ups to monitor side effects and health status. Group 2 participants will also have procedures to prepare the dendritic cell vaccine before the transplant and receive the vaccine after each CT-011 infusion.

After the final treatment, both groups will have follow-up tests at one, three, and six months to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Adults with multiple myeloma eligible for high-dose chemotherapy and stem cell transplant.
  • No active or history of autoimmune disorders, except for stable conditions like Type II diabetes or hypothyroidism.
  • Measurable disease with specific markers in blood or urine.
  • Age 18 or older.
  • Good overall health with a life expectancy of more than nine weeks.
  • Significant bone marrow involvement that can be treated with local anesthesia.
  • Negative pregnancy test and use of effective contraception.
  • Adequate lung and heart function as per specific medical tests.

Exclusion Criteria

  • History of significant blood clots.
  • Significant autoimmune diseases.
  • HIV positive.
  • Serious illnesses like infections needing IV antibiotics or major heart problems.
  • Pregnant or breastfeeding women.
  • History of receiving a donor stem cell or bone marrow transplant.

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