Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma (Vax-DC/MM)
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|ClinicalTrials.gov Identifier: NCT02248402|
Recruitment Status : Unknown
Verified September 2014 by Sung-Hoon Jung, Chonnam National University Hospital.
Recruitment status was: Recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: Vax-DC/MM||Phase 1 Phase 2|
- To create the Vax-DC/MM, myeloma cells will be obtained from the bone marrow of the participants, and leukapheresis will be performed to obtain dendritic cells
- Not everyone who participants in this study will be receiving the same dose of study vaccine. A small group of patients will be enrolled into the study and given a certain dose. If they tolerate it, the next group of patients enrolled will received a higher dose.
- Before the first injection of Vax-DC, low dose cyclophosphamide will be administered to stimulate immune response.
- Participants will be received a certain dose of Vax-DC weekly four times.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2a Study to Evaluate Safety and Efficacy of Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||October 2015|
|Experimental: Vax-DC/MM||Biological: Vax-DC/MM|
- Number of participants with adverse events [ Time Frame: 1 years ]Adverse events were assessed using the National Cancer Institute common toxicity criteria (NCI-CTC) for adverse events version 4.0 every injection of Vax-DC/MM
- Clinical response after completion of Vax-DC/MM injection [ Time Frame: 2 year ]The International Myeloma Working Group uniform criteria were used to assess the clinical response.
- Progression free survival [ Time Frame: 2 year ]Progression free survival was defined as the period from the start of treatment until the end follow-up or death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248402
|Contact: Sung-Hoon Jung, M.D||+82 61 379 email@example.com|
|Korea, Republic of|
|Chonnam National University Hwasun Hospital||Recruiting|
|Hwasun, Jeollanamdo, Korea, Republic of, 519-763|
|Contact: Sung-Hoon Jung, M.D +82 61 379 7622 firstname.lastname@example.org|
|Principal Investigator: Sung-Hoon Jung, M.D|