No registrations found.
ID
Source
Brief title
Health condition
patients with multiple myeloma who have received an autologeous and allogeneic SCT
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of combined DC vaccination and DLI in the induction of graft versus host disease.
Secondary outcome
1. 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.
Background summary
In 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.
Study objective
After 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.
Intervention
1. 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.
Department of Hematology (B02.226),
P.O. Box 85500
H.M. Lokhorst
Utrecht 3508 GA
The Netherlands
+31 (0)88 7557230
h.lokhorst@umcutrecht.nl
Department of Hematology (B02.226),
P.O. Box 85500
H.M. Lokhorst
Utrecht 3508 GA
The Netherlands
+31 (0)88 7557230
h.lokhorst@umcutrecht.nl
Inclusion criteria
1. 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 criteria
1. Acute GvHD > grade A;
2. Extensive chonic GvHD;
3. Cardiac, hepatic, renal or uncontrolled metabolic disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL569 |
| NTR-old | NTR625 |
| Other | : N/A |
| ISRCTN | NO ISRCTN (not randomized) |
Summary results
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