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Vaccination With Dendritic Cell/Tumor Fusions in Conjunction With Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Vaccination With Dendritic Cell/Tumor Fusions in Conjunction With Autologous Stem Cell Transplant in Patients With Multiple Myeloma

- The first group of participants on this study will receive up to 3 monthly doses of the
study vaccine beginning about 1 month following the autologous transplant. If this is
found to be safe, the next group will receive one additional study vaccine prior to the
transplant and then up to 3 doses after the transplant.

- If the screening tests determine that the participant is eligible for the study, they
will undergo dendritic cell collection by a procedure called leukapheresis.
Leukapheresis involves the collection of white blood cells from the blood. Dendritic
cells are grown from these white blood cells in the laboratory. Tumor cells will also
be collected from the bone marrow through a bone marrow aspirate/biopsy.

- After cells have been collected for study vaccine generation, the participant may
receive standard therapy to reduce the number of multiple myeloma cells in the body.
The specific regimen will be determined by the participants multiple myeloma physician.

- The first group of patients will receive the study vaccine only after the transplant.
If this is found safe then the second group will receive a single study vaccine prior
to the transplant.

- Prior to the autologous stem cell transplant, we will harvest stem cells from the
participants blood that will be used for the transplant later. G-CSF will be given as
a daily injection beginning the day after the chemotherapy and GM-CSF injections will
be started seven days after the chemotherapy. These injections will continue until
after the stem cells are collected. Approximately 10 days after the chemotherapy,
participants will undergo a leukapheresis procedure to collect the stem cells.

- Within a few weeks of successful stem cell collection, the participant will be admitted
to the hospital for high dose chemotherapy with autologous stem cell transplantation.

Inclusion Criteria:

- Patients with multiple myeloma who are potential candidates for high dose

- Measurable disease as defined by a history of an elevated M component in plasma,
urine, or free kappa/lambda light chains in the serum

- 18 years of age or older

- ECOG Performance Status of 0-1 with greater than a nine week life expectancy

- Patients with > 20% bone marrow involvement or plasmacytoma amenable to resection
under local anesthesia

- Negative pregnancy test, and adequate contraception method

- DLCO (adjusted)> 50%

- Cardiac Ejection Fraction > 45%

- Laboratory values within the ranges outlined in the protocol

Exclusion Criteria:

- History of clinically significant venous thromboembolism

- Clinically significant autoimmune disease

- HIV positive

- Serious intercurrent illness such as infection requiring IV antibiotics, or
significant cardiac disease characterized by significant arrhythmia, ischemic
coronary disease or congestive heart failure

- Pregnant or lactating women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the toxicity associated with vaccination of multiple myeloma patients with dendritic cell/myeloma fusions and GM-CSF prior to stem cell mobilization and following high dose chemotherapy with stem cell rescue.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

David Avigan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

April 2012

Related Keywords:

  • Multiple Myeloma
  • DC/tumor cell fusions
  • GM-CSF
  • high dose chemotherapy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana-Farber Cancer Institute/Brigham & Women's Hospital Boston, Massachusetts  02115