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Study of Stimuvax in Patients With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy
This study has been completed.

First Received on March 24, 2010.   Last Updated on April 6, 2012   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Anti-MUC1 T-cell response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Various immune response measurements, also in relation to HLA subtypes as available from the various assessment visits [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • Objective clinical response (CR,PR,MR) as defined to Blade criteria over the whole study treatment period until progression disease [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • Time to progression including the whole study treatment period until progression of disease [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • Time to anti-tumor therapy including whole study treatment period and survival follow-up period until anti-tumor therapy is required [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

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:
  • LBLP25 Liposome
  • Stimuvax
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:
  • BLP25 Liposome
  • Stimuvax

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented previously untreated, MUC1-expressing, slowly progressive asymptomatic multiple myeloma with an increasing M-protein concentration displayed on two occasions separated by an interval of at least 4 weeks within the last 18 months, or
  • Documented MUC1-expressing stage II or III multiple myeloma with a treatment-free interval of at least 3 months following prior anti-tumor therapy, and fulfilling criteria for having a stable response/plateau phase.
  • Signed written informed consent
  • MUC1-expressing myeloma cells in the bone marrow
  • Equal to or greater than 18 years of age
  • Life expectancy of at least 6 months
  • ECOG performance status of less than or equal to 1 at study entry
  • Effective contraception for both male and female subjects, if the possibility of conception exists
  • A platelet count ≥100 x 109/L, WBC ≥2.5 x 109/L, and hemoglobin ≥90 g/L
  • Total bilirubin less than or equal to 1.5 x upper reference range
  • AST less than or equal to 2.5 x upper reference range
  • Serum creatinine equal to or less than 2 x upper reference

Exclusion Criteria:

Pre-Therapies:

  • Previous exposure to MUC1 targeting therapy
  • Radiotherapy or any investigational drug in the 30 days before the start of treatment in this study
  • Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization.
  • Any preexisting medical condition requiring chronic oral or intravenous steroid or immunosuppressive therapy except for maintenance doses of prednisone of ≤ 10 mg/day.

Medical Conditions:

  • Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study
  • Hereditary or congenital immunodeficiencies
  • Known hypersensitivity reaction to any of the components of study treatments
  • Clinically significant cardiac disease, e.g., New York Heart Association (NYHA) classes III-IV; unstable angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months
  • Other previous malignancies within 5 years, with exception of a history of a previous basal cell carcinoma of the skin, carcinoma in situ of uterine cervix, gastrointestinal intramucosal carcinoma
  • Known Hepatitis B and/or C
  • Splenectomy

Standard Safety:

  • Known alcohol or drug abuse
  • Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
  • Significant disease which, in the investigator's opinion, would exclude the subject from the study
  • Pregnant or breast-feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator. Subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard
  • Participation in another clinical study within the past 30 days
  • Legal incapacity or limited legal capacity
  • Concurrent treatment with a non-permitted drug
  • Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094548

Locations
Germany
Please call/email Central Contact for Study Location information
Darmstadt, Germany
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Andreas Schroeder, MD Merck KGaA
  More Information

No publications provided

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

Keywords provided by Merck KGaA:
Phase II trial
Randomized
Cancer vaccine
MUC1
BLP 25
Multiple myeloma
BLP25 liposome
Stimuvax

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 23, 2012