An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in relapsed and refractory Multiple Myeloma.
- Conditions
- Multiple myeloma10035227
- Registration Number
- NL-OMON50598
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Subjects who are diagnosed with relapsed and refractory multiple myeloma
defined as:
(1) * 2 prior lines of therapy which must have included at least 2 consecutive
cycles of lenalidomide and a proteosome inhibitor alone or in combination.
(2) Documented refractory or relapsed and refractory multiple myeloma
(3) Refractory to proteosome inhibitor and lenalidomide, and to their last
treatment
(4) Relapsed and refractory patients had achieved at least a partial response
to previous treatment with proteosome inhibitor or lenalidomide, or both, but
progressed within 6 months, and were refractory to their last treatment.
(5) Measurable disease at screening
(6) Eastern Cooperative Oncology Group (ECOG) performance status * 2
1) Target Disease Exceptions
a) Subjects with solitary bone or extramedullary plasmacytoma as the only
evidence of plasma cell dyscrasia.
b) Subjects with monoclonal gammopathy of undetermined significance, smoldering
multiple myeloma (SMM), amyloidosis, POEMS, or Waldenstrom*s macroglobulinemia
c) Subjects with active plasma cell leukemia
2) Medical History and Concurrent Diseases
a) Any uncontrolled or severe cardiovascular or pulmonary disease determined by
the investigator
b) Active infection that requires parenteral anti-infective treatment > 14 days
c) Unable to tolerate thromboembolic prophylaxis while on the study
d) Hypersensitivity reaction to prior IMiD (thalidomide or lenalidomide)
e) Grade 2 peripheral neuropathy (per NCI CTCAE v3.0)
f) Known active hepatitis A, B, or C
g) Known HIV infection
h) Gastrointestinal disease that may significantly alter the absorption of
pomalidomide
i) Prior or concurrent malignancy, except for the following:
i) Adequately treated basal cell or squamous cell skin cancer.
ii) Any cancer (other than in-situ) from which the subject has been disease
free for > 3 years prior to study entry.
3) Prior Therapy or Surgery
a) Prior treatment with pomalidomide.
b) Prior participation in an elotuzumab clinical trial
c) Use of any anti-myeloma drug therapy, within 14 days of the initiation of
study drug treatment or use of any experimental drug therapy or plasmapheresis
within 28 days (or 5 half-lives) whichever is longer of the initiation of study
drug treatment (includes dexamethasone).
d) Treatment with melphalan or monoclonal antibodies within 6 weeks of the
first dose of study drug
e) Prior autologous stem cell transplant within 12 weeks of the first dose of
study drug.
f) Prior allogeneic stem cell transplant except subjects who have completed the
stem cell transplant > 12 months prior to first dose of study drug, have no
history of graft versus host disease, and are not on topical or systemic
immunosuppressive therapy
g) Treatment with corticosteroids within 3 weeks of the first dose of study
drug, except for the equivalent of *10 mg prednisone per day or corticosteroids
with minimal to no systemic absorption or for short course (*4 days) of 40 mg
dexamethasone or equivalent for emergency use
h) Major cardiac surgery within 8 weeks prior to the first dose of study drug;
all other major surgery within 4 weeks prior to the first dose of study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to compare progression free survival (PFS) between<br /><br>the control treatment arm and the investigational treatment arm.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are:<br /><br>1) To compare the objective response rate between the control treatment arm<br /><br>and the investigational treatment arm.<br /><br>('Objective Response Rate' is the percentage of patients whose cancer shrinks<br /><br>or disappears after treatment.)<br /><br>2) To compare overall survival rate between the control treatment arm and the<br /><br>investigational treatment arm.<br /><br>( 'Overall survival rate' is the percentage of people in a clinical trial who<br /><br>are still alive for a certain period of time after they were diagnosed with or<br /><br>started treatment for a disease, such as cancer.)</p><br>