Phase I/II Trial of Combination Plerixafor (AMD3100) and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma
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 |
