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Study Summary
No. 2005-0831:.......Myeloma......Saroj Vadhan-Raj......Cytokines and Supportive Care
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Study Summary Title
Study Summary
Number:
2005-0831
Study Title:An Open-Label Multicenter Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma
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Physician New Patient Referral
Name:Saroj Vadhan-RajPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Cytokines and Supportive CareReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7966
Contact us about clinical trials
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General Information
Disease Group:MyelomaSupported By:Amgen, Inc
Phase of Study:Phase IIReturn
Visit:
One visit for baseline tests and screening. For cycle 1- once a week for 3
weeks. For subsequent cycles-at least 1 visit with each cycle.
Treatment
Agents:
DenosumabHome Care:Routine labs and supportive care as needed.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
NA
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Primary:
1. To estimate overall response rate (CR, PR and minimal response [MR]) and the CR rate in each cohort, relapsed or plateau-phase multiple myeloma.

Secondary:
1. To estimate overall response rate (CR, PR and minimal response [MR]) and the CR rate in each cohort.
2. To chracterize the overall safety profile of densumab in terms of adverse events, antibody formation and survival.

Exploratory:
1. To evaluate time to disease progression, duration of response, the first occurrence of SRE, and progression-free survival.
2. To evaluate the effect of denosumab on bone turnover markers, myeloma associated biomarkers, and myeloma cells by immunohistochemistry.
3. To measure serum trough levels of denosumab.
4. to evaluate the effect of denosumab on patient reported outcomes (PROs).
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Study Status Information
Study Activation / Registration Date:03/15/2006
IRB Review and Approval Date:11/16/2005
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Age >/= 18 yrs, diagnosed with relapsed or plateau-phase multiple myeloma - Relapsed: Have had >/= 2 prior treatment regimens AND relapsed following a response to any conventional multiple myeloma therapy (including Autologous transplntation, immunotherapy, radiation therapy, or other investigational agents). - Plateau-phase: Subjects with myeloma who had a response to their most recent multiple myeloma therapy (including Autologous transplantation or other investigational agents) and have residual detectable serum M-protein level that has been stable >/= 3 mths (< +/ 25% change in M-protein).

2) Measurable disease, defined as a M-protein spike on serum electrophoresis of >/= 0.5 g/dL

3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

4) Life expectancy > 3 months

5) Adequate organ function as defined by: - Serum concentrations of aspartate aminotransferase (AST and alanine aminotransferase (ALT) </= x upper limit of normal (ULN) - Total serum bilirubin </= 2 x ULN - Serum creatinine </= 1.5 x ULN - Platelet count >/= 30 x 10 to the power of 9/L - Hemoglobin concentration >/= 8 g/dL - White blood cell count >/= 2.0 x 10 to the power of 9/L

6) Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:1) Subjects with newly diagnosed myeloma

2) Known neoplastic central nervous system (CNS) abnormality

3) Subjects with non-secretory myeloma, plasma cell leukemia, or plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS syndrome)

4) Prior allogenic stem cell transplant

5) Subjects receiving bisphosphonates (oral or IV) within 2 weeks before enrollment

6) Evidence of any of the following conditions per subject self report or medical cohort review: - Subjects with prior malignancies (except multiple myeloma, basal cell carcinoma or in situ cervical cancer) may be enrolled if disease free for >/= 5 years - Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment - Known infection with human immunodeficiency virus (HIV) - Known active infection with Hepatitis B virus or Hepatitis C virus

7) Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results

8) </= 30 days since receiving an investigational product or device in another clinical trial. ('Investigational is defined as any drug or device not approved for any indication by the applicable regulatory agency). Current enrollment in another clinical trial is not permitted unless the subject's continued participation in the trial is for long-term follow-up/survival data

9) Subjects must agree to use effective contraception during the treatment period. Female subjects with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate

10) Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)

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Links
Registration Number: NCT00259740
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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