Study of Stimuvax in Patients With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy
Summary
The company has temporarily suspended recruitment into and treatment of patients in all recruiting Stimuvax® (BLP25 liposome vaccine) trials worldwide, including EMR63325-008. This is a precautionary measure due to a suspected unexpected serious adverse reaction (SUSAR) in this trial with Stimuvax (Phase II Multiple Myeloma trial EMR63325-008), while we are diligently investigating the cause of this adverse event.
More information can be accessed here: http://www.merck.de/en/media/extNewsDetail.html?newsId=E01571A622782EADC12576EE00702854&newsType=1
Description
L-BLP25 is believed to induce a MUC1-specific T-cell response after vaccination. The primary purpose of this study consists of the ascertainment of a MUC1-specific T-cell response in a specific subject population.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Multiple Myeloma
Intervention
L-BLP25, cyclophosphamide prior to first vaccination, L-BLP25, cyclophosphamide prior to each vaccination, L-BLP25 minus cyclophosphamide
Location
Please call/email Central Contact for Study Location information
Darmstadt
Germany
Status
Suspended
Source
Merck KGaA
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01094548
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:14:57-0400
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Medical and Biotech [MESH] Definitions
Cyclophosphamide
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
Presumed Consent
An institutional policy of granting authority to health personnel to perform procedures on patients or to remove organs from cadavers for transplantation unless an objection is registered by family members or by the patient prior to death. This also includes emergency care of minors without prior parental consent.
Mesna
A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.
Ifosfamide
Positional isomer of CYCLOPHOSPHAMIDE which is active as an alkylating agent and an immunosuppressive agent.
Azathioprine
An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed)
