Panobinostat/Velcade in Multiple Myeloma
| Status: | Archived |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2009 |
| End Date: | June 2011 |
Phase I Exploratory Study of Panobinostat IV in Combination With Bortezomib in Relapsed/Refractory Multiple Myeloma Patients
Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of
hematological tumors, representing the second most frequently occurring hematological
malignancy in the United States. At any one time, 50,000 people suffer from MM, and
approximately 15,000 are diagnosed each year. The median age is approximately 65 years,
although occasionally MM occurs in the second decade of life.
Bortezomib and panobinostat intravenous (IV) are active agents in multiple myeloma and
appear to work through different biochemical pathways, suggesting that there may be a
synergistic effect using the combination. Both compounds have shown anabolic bone effect,
which has been associated to significant anti-myeloma activity.
Primary objectives:
- To assess the toxicity of bortezomib combined with one of 4 doses of panobinostat IV in
patients with relapsed/refractory multiple myeloma, and
- To find the most appropriate doses of bortezomib and panobinostat IV in the
combination.
Secondary objective:
- To assess the effect of bortezomib in combination with panobinostat IV on inducing
osteoblast activation in patients with relapsed/refractory myeloma.
The objective of this study is to identify the maximum tolerated dose (MTD) and assess the
feasibility and toxicity experience for patients with refractory multiple myeloma treated
with bortezomib and one of three doses of panobinostat IV.
Sample Size:
This study will accrue up to 18 patients, in 3 groups of up to 6 patients each, depending on
experiences of DLT. Patients will be studied as follows, Group 1: Bortezomib 1.0 mg/m2 and
panobinostat IV 5 mg/m2 IV, Group 2: Bortezomib 1.0 mg/m2and panobinostat IV 10 mg/m2 IV,
Group 3: Bortezomib 1.0 mg/m2 and panobinostat IV 15 mg/m2 IV and Group 4: Bortezomib 1.0
mg/m2 and panobinostat IV 20 mg/m2 IV. Bortezomib will be given on days 1, 4, 8, and 11
during cycle 1 and cycle 2, and panobinostat will be given on days 1 and 8 of the second
cycle.
If the MTD is not reached with the first group, the second group will be enrolled and will
receive bortezomib1.0 mg/m2 with escalation of panobinostat IV as described above.
Patient population:
Patient's with relapsed/refractory multiple myeloma with at least one line of prior therapy.
Inclusion and exclusion criteria:
Patients must have baseline evaluations performed prior to the first dose of study drug and
must meet all inclusion and exclusion criteria. Results of all baseline evaluations, which
assure that all inclusion and exclusion criteria have been satisfied, must be reviewed by
the principal investigator prior to enrollment of that patient. In addition, the patient
must be thoroughly informed about all aspects of the study, including the study visit
schedule and required evaluations and all regulatory requirements for informed consent. The
written informed consent must be obtained from the patient prior to enrollment. The
following criteria apply to all patients enrolled onto the study unless otherwise specified.
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