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Infusion of host dendritic cells to improve the graft versus myeloma effect of donor lymphocyte infusion. A phase I/II study.


- candidate number1981
- NTR NumberNTR625
- ISRCTNNO ISRCTN (not randomized)
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2006
- Secondary IDsN/A 
- Public TitleInfusion of host dendritic cells to improve the graft versus myeloma effect of donor lymphocyte infusion. A phase I/II study.
- 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 allogeneic stem cell transplantation (SCT) the hematopoiesis is from donor origin. Laboratory and animal studies suggests that de dendritic cells of host origin are important in inducing graft versus myeloma effect and graft versus host disease (GvHD). We hypothesize that infusion of host dendritic cells in patients with multiple myeloma after allogeneic SCT together with donor lymphocyte infusion (DLI) can induce a graft versus myeloma effect.
- Healt Condition(s) or Problem(s) studiedMultiple myeloma (Kahler's disease)
- Inclusion criteria1. Relapse of multiple myeloma; 2. No response of first course of DLI; 3. age 18-70; 4. WHO PS 0-2; 5. Written informed consent.
- Exclusion criteria1. Acute GvHD > grade A; 2. Extensive chonic GvHD; 3. Cardiac, hepatic, renal or uncontrolled metabolic disease.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-mrt-2006
- planned closingdate
- Target number of participants5
- Interventions1. Infusion of DLI together with infusion of APC/dendritic cells; 2. SC injection of APC +/- KLH; 3. APC infusion and injection is repeated 2 times with a 2-week interval; 4. DTH test skin in week 6.
- Primary outcomeFeasibility of combined DC vaccination and DLI in the induction of graft versus host disease.
- Secondary outcome1. Efficacy of combined DC vaccination and DLI to induce a graft versus myeloma response; 2. Effect of combination on the immune status of the recipient in correlation with toxicity and response.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDhr. Prof. Dr. H.M. Lokhorst
- CONTACT for SCIENTIFIC QUERIESDhr. Prof. Dr. H.M. Lokhorst
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Multiple Myeloma Research Foundation (MMRF)
- PublicationsLokhorst HM, DLI for relapsed MM after allogeneic SCT: predictive factors for response and long-term outcome. JCO 00;18:303-37 Lokhorst HM. the occurrence of GvHD is the major predictive factor for response to DLI in MM. Blood 04,103:4362-64 Mapara MY. DLI mediate superior graft vs leukemia effcets in mixed compared to fully allogeneic chimeras: a critical role for host antigen presenting cells. Blood 02,100:1903-09
- Brief summaryIn this study we seek to enhance the positive effects of immunotherapy in multiple myeloma patients. patients with relapse MM who do no respons to their first course of DLI can participate. The second course of DLI (same dose) will be combined with infusion of autologeous dendritic cells, manufactured from stem cells. This infusion will be done 3 times. Primary outcome is the safety of this approach, secondary the efficacy.
- Main changes (audit trail)
- RECORD16-feb-2006 - 26-jun-2006


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