A PHASE 2 MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF POMALIDOMIDE (CC-4047) IN COMBINATION WITH LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA AND MODERATE OR SEVERE RENAL IMPAIRMENT INCLUDING SUBJECTS UNDERGOING HEMODIALYSIS

Phase 2

Completed

Conditions: Multiple myeloma and moderate or severe renal impairment
a type of bone marrow cancer
multiple myeloma

Registration Number: NL-OMON50306

Lead Sponsor: Celgene Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study., 1.
Must be * 18 years at the time of signing the informed consent form., 2.
Understand and voluntarily sign an informed consent document prior to any study
related assessments/procedures being conducted., 3. Able to adhere to the study
visit schedule and other protocol requirements., 4. Subjects must have
documented diagnosis of multiple myeloma and have measurable disease (serum
M-protein * 0.5 g/dL or urine M-protein * 200 mg/24 hours)., 5. Subjects must
have had at least 1 prior antimyeloma regimen including lenalidomide and
documented progression as per the IMWG uniform response criteria (Durie, 2006)
during or after the last antimyeloma regimen. Induction therapy followed by
ASCT and consolidation/ maintenance will be considered as one regimen., 6.
Subjects must have an impaired renal function with an estimated GFR of, < 45
mL/min/1.73 m2 according to the MDRD equation., a. Impaired renal function must
be due to multiple myeloma which needs to be, confirmed by kidney biopsy., b.
Subjects may have acute myeloma related renal failure or chronic myeloma
related renal failure; they may also have been treated with dialysis before,
including dialysis with high cut off membranes., 7. ECOG performance status
score of 0, 1, or 2, 8. Females of childbearing potential must:, a. Have two
negative pregnancy tests as verified by the study doctor prior to starting
study therapy. She must agree to ongoing pregnancy testing during the course of
the study, and after end of study therapy. This applies even if the subject
practices true abstinence from heterosexual contact., b. Either commit to true
abstinence from heterosexual contact (which must be reviewed on a monthly
basis) or agree to use, and be able to comply with, effective contraception
without interruption, 28 days prior to starting IP, during the study therapy
(including dose interruptions), and for 28 days after discontinuation of study
therapy., 9. Male subjects must:, a. Must practice true abstinence or agree to
use a condom during sexual contact with a pregnant female or a female of
childbearing potential while participating in the study, during dose
interruptions and for at least 28 days following IP discontinuation, even if he
has undergone a successful vasectomy.

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment, 1.
Any significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from participating in the study., 2. Any
condition including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study., 3.
Renal insufficiency due to other reasons than multiple myeloma or due to
hypercalcaemia only., 4. Any of the following laboratory abnormalities:, a.
Absolute neutrophil count (ANC) < 1,000/*L, b. Subject with platelet count
< 50,000/*L are not eligible regardless of the percentage of plasma cells in
the bone marrow, c. Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L), d.
Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant
human erythropoietin use is permitted), e. Serum SGOT/AST or SGPT/ALT > 3.0
x upper limit of normal (ULN), f. Serum total bilirubin > 2.0 mg/dL (34.2
*mol/L); or > 3.0 x ULN for subjects with hereditary benign
hyperbilirubinemia, 5. Prior history of malignancies, other than MM, unless the
subject has been free of the disease for * 5 years; exceptions include the
following:, a. Basal or squamous cell carcinoma of the skin, b. Carcinoma in
situ of the cervix or breast, c. Incidental histological finding of prostate
cancer (TNM stage of T1a or T1b), 6. Previous therapy with pomalidomide., 7.
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (this includes
* Grade 3 rash during prior thalidomide or lenalidomide therapy)., 8.
Peripheral neuropathy * Grade 2., 9. Subjects who received an allogeneic bone
marrow or allogeneic peripheral blood stem cell transplant less than 12 months
prior to initiation of study treatment and who have not discontinued
immunosuppressive treatment for at least 4 weeks prior to initiation of study
treatment and are currently dependent on such treatment., 10. Subjects who are
planning for or who are eligible for stem cell transplant.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints:<br /><br>- Overall response rate (ORR) according to the International Myeloma Working<br /><br>Group (IMWG) uniform response criteria with additional clarifications according<br /><br>to the IMWG Consensus panel (Rajkumar, 2011).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br>- Assessment of renal response according to the criteria defined by Dimopoulos<br /><br>and Ludwig (Dimopoulos, 2009; Dimopoulos, 2010 b,c; Ludwig, 2010).<br /><br>- Time to Myeloma response, time to renal response, duration of response (DOR),<br /><br>progression-free survival (PFS), time to progression (TTP), overall survival<br /><br>(OS).<br /><br>- Adverse events (AEs) assessment (type, frequency, seriousness, severity,<br /><br>relationship to pomalidomide and/or dexamethasone and outcomes) including<br /><br>second primary malignancy (SPM).<br /><br>- Pharmacokinetics (PK) of pomalidomide in subjects with relapsed or refractory<br /><br>multiple myeloma and impaired renal function (moderate to severe renal<br /><br>impairment).</p><br>

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A PHASE 2 MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF POMALIDOMIDE (CC-4047) IN COMBINATION WITH LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA AND MODERATE OR SEVERE RENAL IMPAIRMENT INCLUDING SUBJECTS UNDERGOING HEMODIALYSIS

Recruitment & Eligibility

Study & Design

Related Trials

Study at several sites to evaluate pomalidomide taken with dexamethasone (low dose) in patients with Multiple Myeloma (MM) and impaired kidney function who did not respond to the previous treatment or whose disease has returned after the previous treatment

Study at several sites to evaluate pomalidomide taken with dexamethasone (low dose) in patients with Multiple Myeloma (MM) and impaired kidney function who did not respond to the previous treatment or whose disease has returned after the previous treatment

Study at several sites to evaluate pomalidomide taken with dexamethasone (low dose) in patients with Multiple Myeloma (MM) and impaired kidney function who did not respond to the previous treatment or whose disease has returned after the previous treatment

Study at several sites to evaluate pomalidomide taken with dexamethasone (low dose) in patients with Multiple Myeloma (MM) and impaired kidney function who did not respond to the previous treatment or whose disease has returned after the previous treatment

Study at several sites to evaluate pomalidomide taken with dexamethasone (low dose) in patients with Multiple Myeloma (MM) and impaired kidney function who did not respond to the previous treatment or whose disease has returned after the previous treatment

Study at several sites to evaluate pomalidomide taken with dexamethasone (low dose) in patients with Multiple Myeloma (MM) and impaired kidney function who did not respond to the previous treatment or whose disease has returned after the previous treatment

Study at several sites to evaluate pomalidomide taken with dexamethasone (low dose) in patients with Multiple Myeloma (MM) and impaired kidney function who did not respond to the previous treatment or whose disease has returned after the previous treatment

A study to determine the safety and efficacy for the combination of durvalumab and daratumumab (D2) to treat relapsed and refractory multiple myeloma.

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