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| Sponsor: | Merck KGaA |
|---|---|
| Information provided by (Responsible Party): | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01094548 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Biological: L-BLP25, cyclophosphamide prior to first vaccination Biological: L-BLP25 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study With Stimuvax (L-BLP25) in Subjects With Either Chemotherapy-naïve, Slowly Progressive, Asymptomatic Multiple Myeloma or With Stage II/III Multiple Myeloma in Stable Response/Plateau Phase Following Anti-tumor Therapy |
| Enrollment: | 34 |
| Study Start Date: | February 2008 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Biological: L-BLP25, cyclophosphamide prior to first vaccination
A single i.v. dose of cyclophosphamide (300 mg/ m²) at day -3 prior to the start of vaccination with L-BLP25, after which L-BLP25 is administered weekly for a period of 8 weeks, followed by a period of maintenance treatment starting at week 14 in which maintenance vaccinations are administered every 6 weeks until disease progression requiring anti-tumor therapy. One vaccination will consist of four injections administered at four defined sites.
Other Names:
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| Experimental: B |
Biological: L-BLP25
Subjects will receive the same treatment as arm A after the clinical hold, i.e.L-BLP25 is administered weekly for a period of 8 weeks (without cyclophosphamide) , followed by a period of maintenance treatment starting at week 14 in which maintenance vaccinations are administered every 6 weeks until disease progression requiring anti-tumor therapy. One vaccination will consist of four vaccinations administered at four defined sites.
Other Names:
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-Therapies:
Medical Conditions:
Standard Safety:
Contacts and Locations
More Information
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01094548 History of Changes |
| Other Study ID Numbers: | EMR63325-008 |
| Study First Received: | March 24, 2010 |
| Last Updated: | April 6, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
|
Phase II trial Randomized Cancer vaccine MUC1 |
BLP 25 Multiple myeloma BLP25 liposome Stimuvax |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders |
Immune System Diseases Cyclophosphamide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |