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Last Updated: January 18, 2020

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CLINICAL TRIALS PROFILE FOR LENALIDOMIDE

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505(b)(2) Clinical Trials for Lenalidomide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00974233 Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL Completed Celgene Corporation Phase 2 2009-10-01 The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination NCT00974233 Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL Completed University of Wisconsin, Madison Phase 2 2009-10-01 The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination NCT01245673 Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma Active, not recruiting University of Pennsylvania Phase 2 2011-04-01 One purpose of this study is to find out if a new combination of immune system treatments (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection ("immunity") against the myeloma cells. A second purpose is to find out how well this combination of immune system treatments is able to control the myeloma.
New Combination NCT01755975 Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma Active, not recruiting Biologics, Inc. Phase 1/Phase 2 2012-12-01 The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination NCT01755975 Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma Active, not recruiting Celgene Corporation Phase 1/Phase 2 2012-12-01 The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lenalidomide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00031941 CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy Completed National Cancer Institute (NCI) Phase 1 2002-04-01 RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.
NCT00031941 CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy Completed National Institutes of Health Clinical Center (CC) Phase 1 2002-04-01 RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.
NCT00036894 CC-5013 in Treating Patients With Recurrent Glioma Completed National Cancer Institute (NCI) Phase 1 2002-03-01 RATIONALE: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma.
NCT00046735 Phase 1 Study OF CDC-501 in Patients With Solid Tumors Completed Celgene Corporation Phase 1 2002-06-01 To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.
NCT00056160 CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma Completed Celgene Corporation Phase 3 2003-01-01 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 in a treatment phase and a follow-up phase.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lenalidomide

Condition Name

Condition Name for Lenalidomide
Intervention Trials
Multiple Myeloma 280
Chronic Lymphocytic Leukemia 44
Lymphoma 34
Myeloma 25
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Condition MeSH

Condition MeSH for Lenalidomide
Intervention Trials
Multiple Myeloma 417
Neoplasms, Plasma Cell 406
Lymphoma 187
Leukemia 120
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Clinical Trial Locations for Lenalidomide

Trials by Country

Trials by Country for Lenalidomide
Location Trials
Canada 211
Japan 99
United Kingdom 89
Australia 81
Belgium 50
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Trials by US State

Trials by US State for Lenalidomide
Location Trials
New York 179
California 152
Texas 149
Ohio 127
Florida 125
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Clinical Trial Progress for Lenalidomide

Clinical Trial Phase

Clinical Trial Phase for Lenalidomide
Clinical Trial Phase Trials
Phase 4 13
Phase 3 98
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Lenalidomide
Clinical Trial Phase Trials
Recruiting 245
Completed 195
Active, not recruiting 187
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Clinical Trial Sponsors for Lenalidomide

Sponsor Name

Sponsor Name for Lenalidomide
Sponsor Trials
Celgene Corporation 266
National Cancer Institute (NCI) 142
Celgene 69
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Sponsor Type

Sponsor Type for Lenalidomide
Sponsor Trials
Other 847
Industry 656
NIH 153
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