Trial record 13 of 18 for:    plerixafor and mm

Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborators:
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00903968
First received: May 18, 2009
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.


Condition Intervention Phase
Multiple Myeloma
Drug: Plerixafor (AMD3100)
Drug: bortezomib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the safety of plerixafor and bortezomib, to identify the maximum tolerated dose of plerixafor and bortezomib and to assess the response rate of plerixafor and bortezomib in patients with relapsed or relapsed/refractory multiple myeloma. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess time to progression. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess duration of response. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess mobilization of MM cells and other BM microenvironment cells. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine the degree of apoptosis in mobilized MM cells. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 69
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plerixafor (AMD3100)and Bortezomib
Plerixafor (AMD3100)and Bortezomib
Drug: Plerixafor (AMD3100)
Given subcutaneously on days 1 through 6.
Other Name: AMD3100
Drug: bortezomib
Given intravenously on days 3, 6, 10 and 13 (90 minutes after AMD3100)
Other Name: velcade

Detailed Description:
  • Since we are looking for the highest doses of the combined study drugs that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma not everyone who participates will receive the same dose of the study drug. The dose the participant receives will depend on the number of participants who have been in the study before them and if they have tolerated their doses.
  • Plerixafor will be given as an injection under the skin on days 1, 2, 4 and 5. Participants will receive plerixafor and bortezomib on days 3 and 6 and bortezomib alone on days 10 and 13. Bortezomib is administered intravenously. Each treatment cycle will last 21 days.
  • The cycles will be repeated for up to 8 cycles as long as the participant does not have any severe or unmanageable side effects as the disease is responding to the study drug.
  • While receiving study drugs and before the start of each study cycle, participants will come to the clinic and the following will be performed: physical exam, questions about current health and current medications, blood work, urine sample, x-rays (if deemed necessary) and EKG.
  Eligibility

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

Inclusion Criteria:

  • 18 years of age or older
  • Must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. Prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib
  • Monoclonal protein serum of 1gm/dL or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dL or greater, or measurable plasmacytoma
  • ECOG Performance Status 0, 1, or 2
  • Laboratory values as outlined in the protocol

Exclusion Criteria:

  • Uncontrolled infection
  • Cytotoxic chemotherapy < 3 weeks, or biologic or targeted novel therapy < 2 weeks, or corticosteroids < 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
  • Pregnant women
  • Nursing women
  • Men or women of child-bearing potential who are unwilling to employ adequate contraception
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
  • Known to be HIV positive
  • Radiation therapy < 2 weeks prior to registration
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903968

Contacts
Contact: Irene Ghobrial, MD 617-632-4198 irene_ghobrial@dfci.harvard.edu
Contact: Stacey Chuma, RN 617-632-4863 stacey_chuma@dfci.havard.edu

Locations
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Kenneth H Shain, M.D., Ph.D.    813-745-6841    Ken.Shain@moffitt.org   
Principal Investigator: Kenneth H Shain, M.D., Ph.D.         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Irene Ghobrial, MD         
Cape Cod Hospital Recruiting
Hyannis, Massachusetts, United States, 02601
Contact: Frank Basile, MD    508-862-7575    fgbasile@capecodhealth.org   
Principal Investigator: Frank Basile, MD         
Milford Hospital Recruiting
Milford, Massachusetts, United States, 01757
Contact: Michael Constantine, MD    508-488-3700    Michael_Constantine@dfci.harvard.edu   
Principal Investigator: Michael Constantine, MD         
Newton-Wellesley Hospital Recruiting
Newton, Massachusetts, United States, 02462
Contact: Caroline Block, MD    617-658-6000    cblock@partners.org   
Principal Investigator: Caroline Block, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Irene Ghobrial, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00903968     History of Changes
Other Study ID Numbers: 08-273
Study First Received: May 18, 2009
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
refractory
relapsed
bortezomib
AMD3100
plerixafor

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
JM 3100
Bortezomib
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 27, 2014