An open-label pilot clinical trial of MAGE-A3 and MAGE-C1 mRNA electroporated autologous dendritic cell vaccination in combination with lenalidomide maintenance therapy for multiple myeloma after first-line autologous stem cell transplantation.

• Conditions: Symptomatic Multiple Myeloma after first-line autologous stem cell transplantation; MedDRA version: 16.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-000795-15-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-05
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

For the standard primary treatment phase:
1.Able and willing to give valid written informed consent (IC1) before additional blood and bone marrow samples are collected.
2.Patients must have newly diagnosed symptomatic multiple myeloma.
3.Measurable disease.
4.Age at diagnosis : 18- 65 years.
5.Eligible for autologous stem cell transplantation.
6.Collection of adequate bone-marrow samples to construct patient-specific PCR probes for minimal residual disease analysis

For leukapheresis:
1.Able and willing to give valid written informed consent (IC2) before leukapheresis.
2.Having reached at least partial remission after autolous stem cell transplantation.

For the experimental treatment phase:
1.Able and willing to give valid informed consent (IC3) before the start of the experimental treatment
2.At least in complete remission or very good partial response after autologous stem cell transplantation with or without consolidation
3.Eastern Cooperative Oncology Group performance status of 0 or 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

EXCLUSION CRITERIA FOR STANDARD TREATMENT PHASE
Patients will be excluded for enrolment if they fulfil any of the following criteria:
1.Multiple myeloma of IgM subtype
2.POEMS syndrome
3.Plasma cell leukaemia or circulating plasma cells > 2 x 10E9/L.
4.Waldenstrom’s macroglobulinemia
5.Patients with known amyloidosis
6.HIV, HbsAg or hepatitis C serology positivity
7.History of other malignancy (other than basal cell carcinoma and carcinoma of the cervix in situ)
8.Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to start standard treatment phase.
9.Female patients who are pregnant or lactating.
10.Any other clinically significant medical disease or psychiatric condition that, in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.

EXCLUSION CRITERIA FOR EXPERIMENTAL TREATMENT PHASE
1.Concomitant chemotherapy or other antimyeloma treatment
2.Concomitant immunosuppressive drugs including glucocorticosteroids
3.Any other clinically significant medical disease or psychiatric condition that, in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified