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Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma


- 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Irene Ghobrial, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

08-273

NCT ID:

NCT00903968

Start Date:

May 2009

Completion Date:

June 2014

Related Keywords:

  • Multiple Myeloma
  • refractory
  • relapsed
  • bortezomib
  • AMD3100
  • plerixafor
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Cape Cod Hospital Hyannis, Massachusetts  02601
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Newton-Wellesley Hospital Newton, Massachusetts  02462
Moffitt Cancer Center Tampa, Florida  33612
Milford Hospital Milford, Massachusetts  01757