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Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02666209
Expanded Access Status : No longer available
First Posted : January 28, 2016
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute

Brief Summary:
Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are currently participating in a clinical trial which is closing. This research study is studying Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657

Condition or disease Intervention/treatment
Multiple Myeloma in Relapse Multiple Myeloma Drug: Ulocuplumab Drug: Lenalidomide Drug: Bortezomib Drug: Dexamethasone

Detailed Description:

This research study is an Expanded Access Trial, which is a way to provide an investigational therapy to individuals who are not eligible to receive that therapy in a clinical trial, but have a serious or life-threatening illness for which other treatments are not available.

The purpose of this expanded access program is to treat participants diagnosed with relapsed or refractory multiple myeloma with an investigational drug called ulocuplumab.

Participants enrolled in the program will receive ulocuplumab with lenalidomide and dexamethasone or ulocuplumab with bortezomib and dexamethasone. Ulocuplumab is supposed to kill myeloma cells.

Lenalidomide, which is also known as Revlimid® and Bortezomib, which is also known as Velcade®, are approved by the FDA for treatment of Multiple Myeloma. Dexamethasone, also known as Decadron®, is also approved by the FDA for other treatments. It is a type of steroid medication that fights inflammation.

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Study Type : Expanded Access
Official Title: Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma



Intervention Details:
  • Drug: Ulocuplumab
    CXCR4 inhibitor given weekly on a 28 day cycle intravenously
    Other Name: BMS-936564
  • Drug: Lenalidomide
    immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomib
    Other Name: Revlimid
  • Drug: Bortezomib
    proteasome inhibitor given at physician discretion in subjects not receiving lenalidomide
    Other Name: Velcade
  • Drug: Dexamethasone
    steroid given at physician discretion on a 28 day cycles
    Other Name: Decadron

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Signed informed consent document
  • Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), tolerating therapy, and still receiving benefit from treatment.

Exclusion Criteria:

  • Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocol CA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days; antibody against CXCR4 within 10 weeks).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666209


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Bristol-Myers Squibb
Investigators
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Principal Investigator: Irene M Ghobrial, MD Dana-Farber Cancer Institute
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Responsible Party: Irene Ghobrial, MD, Irene M. Ghobrial, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02666209    
Other Study ID Numbers: 16-002
CA212-122 ( Other Identifier: Bristol-Myers Squibb )
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Keywords provided by Irene Ghobrial, MD, Dana-Farber Cancer Institute:
Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Additional relevant MeSH terms:
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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
Dexamethasone
Lenalidomide
Bortezomib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors