Chemotherapy, Vaccine Therapy, and Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Completed · Phase 1/Phase 2
Conditions studied: Multiple Myeloma
In brief
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with vaccine therapy and peripheral stem cell transplantation may be effective in treating multiple myeloma. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine therapy and peripheral stem cell transplantation in treating patients who have newly diagnosed multiple myeloma.
Key facts
- Study ID
- NCT00024466
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 28
- Starts
- 2001-04-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2018-09-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Initial Presentation
- Age between 18 and 70 years
- ECOG 0 - 2
- Patients with histologically confirmed multiple myeloma with ≥ 30% bone
- marrow involvement and a de novo presentation. One cycle of prior
- chemotherapy for myeloma is allowed. Local radiation therapy is permitted
- Ability to give informed consent
- No existing secondary malignancies and no history of secondary malignancies in the past 5 years (other than a history of carcinoma in situ of the cervix, superficial skin cancer, or superficial bladder cancer)
- No active autoimmune disease, nor a history of any autoimmune disease requiring medical treatment with systemic immunosuppressants
- No corticosteroids within 28 days of tumor harvest
- No major active medical or psychosocial problems that could be exacerbated or complicated by this treatment
- Not pregnant
- HIV negative
- AST/ALT, total bilirubin < threefold normal
- Absolute neutrophil count >500/mm3
- Platelet count >30,000/mm3
- Prior to Transplantation
- ECOG performance status of 0 - 2.
- No active/uncontrolled infection.
- Absolute neutrophil count (ANC) >1000/mm3.
- Platelet count >50,000/mm3.
- Hemoglobin >8g/dL
- AST/ALT, total bilirubin <3-fold normal.
- 50% or greater reduction in tumor burden with prior chemotherapy
- Patient has received a minimum of 2 cycles of an accepted induction
You may not qualify if…
- Failure of autologous tumor-cell processing for vaccine production
Where it is running
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.