Study of Natalizumab in Relapsed/Refractory Multiple Myeloma - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00675428

Purpose

Preclinical data support the evaluation of natalizumab in oncology as a single agent or in combination with standard anti-cancer therapies. Therefore, natalizumab is being developed for the treatment of patients with relapsed or refractory multiple myeloma.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Natalizumab 300 mg Drug: Natalizumab 450 mg	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1/2, Two-Arm, Dose-Finding Study of Natalizumab for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma.

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Natalizumab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To evaluate the safety profile of 2 dose levels of natalizumab in subjects with relapsed or refractory multiple myeloma [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
To evaluate the anti-tumor activity of 2 dose levels of natalizumab in this study population [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
300 mg Treatment Arm: Experimental	Drug: Natalizumab 300 mg Intravenous (IV) infusions of natalizumab once every 28 days for 6 months.
450 mg Treatment Arm: Experimental	Drug: Natalizumab 450 mg Intravenous (IV) infusions of natalizumab once every 28 days for 6 months.

Eligibility

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

Criteria

Inclusion Criteria:

Age >/=18 years at the time of informed consent
Relapsed or refractory multiple myeloma that was treated with or was considered inappropriate for treatment with bortezomib and an IMiD drug (including an analogue).
ECOG Performance Status </=2.
Corrected calcium <10.6 mg/dL

Exclusion Criteria:

Candidates for stem cell transplantation willing to undergo transplantation. (Subjects who are candidates for stem cell transplantation, but are not willing to undergo transplant will be eligible for the study.)
Autologous stem cell transplantation <3 months post transplant.
Prior allogeneic stem cell transplantation.
Non secretory myeloma.
Plasma cell leukemia (>2000/uL circulating plasma cells by standard cell counting differential), hyperleukocytosis (white blood cells >100,000/uL, clinical evidence of hyperviscosity syndrome, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome), or primary systemic amyloidosis.
Subjects who cannot undergo a brain MRI study.
Clinically significant (as determined by the Investigator) 12 lead electrocardiogram (ECG) abnormalities, including QTc prolongnation (>450 ms in males; >470 ms in females).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675428

Contacts

Contact: Biogen Idec

oncologyclinicaltrials@biogenidec.com

Locations

United States, Arizona
Research Site	Recruiting
Scottsdale, Arizona, United States
United States, Minnesota
Research Site	Recruiting
Rochester, Minnesota, United States

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

Responsible Party:	Biogen Idec ( Biogen Idec )
Study ID Numbers:	101MY201
Study First Received:	May 6, 2008
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00675428 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Relapsed or refractory Multiple Myeloma

Study placed in the following topic categories:

Signs and Symptoms
Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 10, 2009