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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28206

Enrollment

Registered

2006-02-16

Start date

2006-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with multiple myeloma who have received an autologeous and allogeneic SCT

Interventions

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.

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Acute GvHD > grade A; 2. Extensive chonic GvHD; 3. Cardiac, hepatic, renal or uncontrolled metabolic disease.

Design outcomes

Primary

Measure	Time frame
Feasibility of combined DC vaccination and DLI in the induction of graft versus host disease.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactH.M. Lokhorst

University Medical Center Utrecht (UMCU), Department of Hematology (B02.226), P.O. Box 85500

h.lokhorst@umcutrecht.nl+31 (0)88 7557230

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)