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Dendritic cell vaccination in multiple myeloma.


- candidate number5998
- NTR NumberNTR1872
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jun-2009
- Secondary IDsUMCU METC 05/263
- Public TitleDendritic cell vaccination in multiple myeloma.
- Scientific TitleInfusion of Host Dendritic Cells to improve the Graft versus Myeloma effect of Donor Lymphocyte Infusion. A phase I /II study.
- ACRONYMAPC study
- hypothesisAfter non-myeloablative allogeneic SCT the hematopoiesis is from donor origin (100% donor chimerisme) in almost all cases. The origin of DCs is important in presenting minor antigens to donor T-cells. Autologous or host DCs are capable to directly present minor antigens, while donor DCs can present minor antigens only by cross presentation, which implies active uptake of recipient antigens. As such, host DCs are much better capable to induce graft versus myeloma and graft versus host disease. This concept was confirmed in animal studies and is suggested to be important in humans.

Primary objective:
To evaluate the feasibility of combined DC vaccination and DLI, in the induction of graft-versus-host disease.
Secondary objective:
1. To evaluate the efficacy of combined DC vaccination and DLI to induce a graft-versus-myeloma response;
2. To evaluate the effect of combined DC vaccination and DLI on the immune status of the recipient in correlation with toxicity and response.
- Healt Condition(s) or Problem(s) studiedMultiple myeloma
- Inclusion criteria1. Multiple myeloma patients with relapsed disease after a non- myeloablative allo-SCT, who have not responded 3 months after a first course of DLI with 1 x 107 T cells/kg body weight;
OR
2. Multiple patients who have received a non myeloablative Allo-SCT from a sibling or MUD donor for relapsed disease after a previous autologous SCT and who have not responded 3 months after a first course of pre-emptive DLI with 1 x 107 T cells/kg (1 x 106 T cells/kg, in case of MUD) cells/kg body weight;
AND
3. Age 18-70 years;
4. Absence of acute GvHD > grade A;
5. Absence of extensive chronic GvHD;
6. WHO performance 0-2;
7. Absence of severe cardiac hepatic, renal, metabolic disease;
8. Written informed consent.
- Exclusion criteriaNot further specified.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 11-aug-2006
- planned closingdate
- Target number of participants10
- InterventionsAdministration of autologeous dendritic cells combined with donor T-cells.
- Primary outcomeToxicity.
- Secondary outcomeEfficacy.
- TimepointsDendritic cell vaccination is given at 0, 2 and 4 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDhr. Prof. Dr. H.M. Lokhorst
- CONTACT for SCIENTIFIC QUERIESMD, PhD M.C. Minnema
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-jun-2009 - 6-okt-2009


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