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Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma

2014-08-27 03:55:05 | BioPortfolio

Summary

For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline.

Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter.

Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

CC-5013

Location

Palo Verde Hematology Oncology
Glendale
Arizona
United States
85304

Status

Completed

Source

Celgene Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:05-0400

Clinical Trials [1326 Associated Clinical Trials listed on BioPortfolio]

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

This is an international, multicenter, open-label, single-arm study for advanced Multiple Myeloma patients who had previously taken high-dose dexamethasone alone or thalidomide plus high-d...

A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or identically appearing placebo to CC-5013 plus high-dose dexamethasone, in 4-week cycles. For each subject the study...

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate...

A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

To evaluate the response rate, response duration, and survival of patients treated with CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.

A Study of Doxil, Vincristine and Decadron (DVd) +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)

A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma

PubMed Articles [5569 Associated PubMed Articles listed on BioPortfolio]

Organochlorine Levels in Plasma and Risk of Multiple Myeloma: Organochlorines and risk of multiple myeloma.

To estimate the association between organochlorine pesticides and polychlorinated biphenyls (PCBs) and multiple myeloma (MM).

Multiple Myeloma Presenting as a Superscan on 68Ga-Pentixafor PET/CT.

A 60-year-old woman diagnosed with multiple myeloma was referred for Ga-pentixafor PET/CT for evaluation of the disease. Diffuse and intense radioactivity throughout the axial and proximal appendicula...

Shall we treat smoldering multiple myeloma in the near future?

In recent years, several new drugs have been approved for the treatment of multiple myeloma. Many of these newer drugs are highly efficacious and less toxic than older chemotherapy drugs. In 2014, the...

Early relapsed disease of multiple myeloma following up-front HDM-ASCT: a study based on the Danish Multiple Myeloma Registry in the period 2005 to 2014.

Daratumumab resistance is frequent in advanced stage multiple myeloma patients irrespectively of CD38 expression, and is related to dismal prognosis.

Daratumumab is a promising new anti-myeloma agent. We report a single center "real world" series of multiple myeloma (MM) and amyloidosis (AL) patients treated with daratumumab.

Medical and Biotech [MESH] Definitions

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.

A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

Class I human histocompatibility (HLA) antigens encoded by a small cluster of structural genes at the C locus on chromosome 6. They have significantly lower immunogenicity than the HLA-A and -B determinants and are therefore of minor importance in donor/recipient crossmatching. Their primary role is their high-risk association with certain disease manifestations (e.g., spondylarthritis, psoriasis, multiple myeloma).

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