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

This study is currently recruiting participants.
Verified June 2013 by Dana-Farber Cancer Institute
Sponsor:
Collaborators:
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00903968
First received: May 18, 2009
Last updated: June 19, 2013
Last verified: June 2013

May 18, 2009
June 19, 2013
May 2009
December 2013   (final data collection date for primary outcome measure)
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 ]
  • 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: No ]
  • To evaluate the safety of plerixafor and bortezomib in patients with multiple myeloma. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To identify the maximum tolerated dose of plerixafor and bortezomib. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00903968 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma

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.

  • 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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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
Experimental: Plerixafor (AMD3100)and Bortezomib
Plerixafor (AMD3100)and Bortezomib
Interventions:
  • Drug: Plerixafor (AMD3100)
  • Drug: bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Irene Ghobrial, MD 617-632-4198 irene_ghobrial@dfci.harvard.edu
Contact: Stacey Chuma, RN 617-632-4863 stacey_chuma@dfci.havard.edu
United States
 
NCT00903968
08-273
Yes
Irene Ghobrial, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Genzyme, a Sanofi Company
Principal Investigator: Irene Ghobrial, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP