Articles tagged with: Clinical Trial

Press Releases»

[ by | Nov 27, 2018 7:30 am | Comments Off ]
Celgene Corporation And Bluebird Bio Complete Enrollment Of Pivotal KarMMa Study Of Anti-BCMA CAR T-Cell Therapy bb2121 In Patients With Relapsed And Refractory Multiple Myeloma

Summit, NJ and Cambridge, MA (Press Release) – Celgene Corpo­ra­tion (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the com­ple­tion of en­roll­ment for the KarMMa pivotal study of bb2121, the com­pa­nies’ lead inves­ti­ga­tional anti-BCMA CAR T cell ther­apy can­di­date for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. bb2121 is being devel­oped as part of a Co-Development, Co-Promote and Profit Share Agreement be­tween Celgene and bluebird bio.

“We con­tinue to be ex­cited about bb2121 as a poten­tial first-in-class BCMA-targeted ther­apy for patients with mul­ti­ple myeloma,” said Alise Reicin, M.D., Pres­i­dent, Global …

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[ by | Jul 7, 2015 2:16 pm | 17 Comments ]
Daratumumab Expanded Access Program Initiated

A new pro­gram has been started that will make it easier for re­lapsed mul­ti­ple myeloma patients in the United States to be treated with the in­ves­ti­ga­tion­al drug daratumumab.

Johnson & Johnson (NYSE:JNJ), which is devel­op­ing dara­tu­mu­mab in col­lab­o­ra­tion with the Danish bio­technology com­pany Genmab, has ini­ti­at­ed an “ex­panded access pro­gram” – a special kind of clin­i­cal trial – to broaden op­por­tu­ni­ties for qualify­ing U.S. myeloma patients to be treated with the drug.

The pro­gram is ex­pec­ted to remain in place until a de­ci­sion is made by the U.S. Food & …

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[ by | Aug 6, 2014 3:57 pm | One Comment ]

Constellation Pharmaceuticals recently initiated a Phase 1 clinical trial that will test whether single-agent CPI-0610 is safe and effective as an anti-myeloma therapy.

The clinical trial is taking place at a several locations across the United States, and is open to multiple myeloma patients who have relapsed after at least one previous myeloma treatment regimen.

CPI-0610 is a small molecule that inhibits bromodomain and extra-terminal (BET) proteins, which are involved in regulating the cell cycle and cell death. Bromodomain inhibitors, which include the compound JQ1, have attracted attention in recent years as potential treatments for a range of different cancers, including multiple myeloma.

A Phase 1 clinical trial of CPI-0610 as a potential treatment for lymphoma has been ongoing since last summer. The Phase 1 trial in myeloma and another Phase 1 trial in patients with acute leukemias and myelodysplastic syndromes have been added based on preclinical research showing blood-related cancers may be highly sensitive to BET inhibition.

For more information about the trial, see the trial description at the U.S. clinical trial registry.

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[ by | Sep 5, 2011 9:07 am | One Comment ]

Reduced-Dose Velcade-Thalidomide-Dexamethasone Is Effective For Newly Diagnosed Myeloma – Recently published results from a French study show that the com­bi­na­tion of reduced-dose Velcade (bor­tez­o­mib) and thalidomide (Thalomid) plus dexamethasone (Decadron) is safer and more effective than standard-dose Velcade plus dexa­meth­a­sone for the treat­ment of newly diagnosed multiple myeloma patients. The results were pre­vi­ously presented at the American Society of Clinical Oncology (ASCO) meeting in June 2010. Results showed that after four cycles of ther­apy, patients who received the reduced-dose three-drug com­bi­na­tion had a significantly higher response rate and experienced fewer side effects than patients receiving the standard-dose regi­men. The same group of patients con­tinued to have a higher response rate after stem cell trans­planta­tion. For a more detailed summary of the results, please see the Beacon’s coverage of the ASCO presentation or the study in the journal Blood (abstract).

Phase 3 Clinical Trial Investigating The Need For Stem Cell Transplantation Is Recruiting Myeloma Patients – Newly diagnosed multiple myeloma patients under the age of 65 years are being recruited at various cancer centers across the United States for a Phase 3 clinical trial that will in­ves­ti­gate whether stem cell trans­plants are necessary in the era of novel agents.  All participants will be treated with a com­bi­na­tion of Revlimid (lena­lido­mide), Velcade, and dexa­meth­a­sone.  Half of the patients will then also receive a stem cell trans­plant.  Based on the results, researchers will determine whether stem cell trans­planta­tion sig­nificantly extends pro­gres­sion-free survival. For more in­­for­ma­tion or to enroll, please see the clinical trial description.

Teleconference On Clinical Trial Participation – On Thursday, the Inter­na­tional Myeloma Foundation will sponsor a teleconference about the importance of participating in clinical trials.  Dr. Brian Durie, a myeloma specialist at Cedars-Sinai Cancer Center, will discuss the Phase 3 clinical trial comparing carfilzomib-Revlimid-dexamethasone and Revlimid-dexamethasone alone.  The call will be held from 4 p.m. to 5 p.m. PT.  For more in­­for­ma­tion, please see the International Myeloma Foundation website.

For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.

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[ by | Aug 30, 2011 3:36 pm | Comments Off ]

Dr. Adam Cohen Joins The Myeloma Beacon’s Medical Advisor Team Dr. Adam Cohen, an assistant professor of clinical oncology at the Fox Chase Cancer Center in Philadelphia, has joined The Myeloma Beacon’s team of Medical Advisors. Beacon Medical Advisors assist with answering medical questions posted in the Beacon’s multiple myeloma forums. For more information about getting medical advice answered in the forums, please see these instructions.

Senesco Technologies And Mayo Clinic To Begin Clinical Trial Of SNS01-T For Myeloma – On August 24, Senesco Technologies announced an agreement with the Mayo Clinic to conduct a clinical trial to study SNS01-T, an investigational drug that Senesco is developing for multiple myeloma. The trial will assess the safety, tolerability, and efficacy of SNS01-T in relapsed as well as refractory multiple myeloma patients. The trial is expected to start by the end of September.  For more information, please see the Senesco website.

Retaspimycin Shows Modest Activity In Phase 1 Trial For Myeloma – Results from a Phase 1 clinical trial showed that retaspimycin hydrochloride (IPI-504), an investigational drug being developed by Infinity Pharmaceuticals, has modest activity in relapsed and refractory multiple myeloma patients. Retaspimycin stabilized disease in four of eighteen patients participating in the trial. The most common side effect was pain at the infusion site.  All side effects were mild or moderate. For more information, see the study in the journal Leukemia and Lymphoma (abstract).

Boston Workshop For Multiple Myeloma Patients – The Multiple Myeloma Research Foundation (MMRF) will hold a one-day workshop for myeloma patients and their families on September 9 in Boston. Dr. Paul Richardson, a myeloma expert from the Dana-Farber Cancer Institute, will lead the program. Throughout the day, myeloma experts will talk about prognosis, treatments for newly diagnosed and relapsed/refractory patients, supportive care options, and clinical trials. The specialists will also be available to answer questions. Registration will begin at 9 a.m., and the program will run from 10 a.m. until 3.30 p.m. at the Westin Copley Place. For more information or to register, please see the MMRF website.

For a more detailed list of myeloma-related events, please see the Myeloma Beacon Events Calendar.

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[ by and | May 25, 2011 6:26 pm | One Comment ]
Myeloma Research To Be Presented At The American Society of Clinical Oncology’s 47th Annual Meeting (ASCO 2011)

The 47th annual meeting of the American Society of Clinical Oncology (ASCO) will take place Friday, June 3, through Tuesday, June 7, in Chicago.

More than 30,000 clin­i­cal spe­cialists from all over the world are ex­pected to attend the five-day meeting to discuss the cur­rent re­search in cancer treat­ment and care. This year’s meeting will primarily focus on the theme of “Patients, Pathways, Progress.”

The meeting will in­clude many pre­sen­ta­tions and seminars focused spe­cif­i­cally on mul­ti­ple myeloma. The ASCO website cur­rently lists over 40 myeloma-based abstracts.

The Myeloma Beacon will be …

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[ by | May 16, 2011 2:15 pm | Comments Off ]

University Of Arkansas Begins Phase 2 Study Of Natural Killer Cell Therapy For Multiple Myeloma – Researchers at the University of Arkansas for Medical Sciences are cur­rently recruiting high-risk, re­lapsed multiple myeloma patients to par­tic­i­pate in a Phase 2 clin­i­cal trial investigating the effectiveness of natural killer cell ther­apy. A natural killer cell is a type of white blood cell that fights cancer cells. Participants will be treated with Velcade (bor­tez­o­mib) as well as natural killer cell infusions and protein infusions that increase natural killer cell activity.  Natural killer cells for each participant will be obtained from a family member, if avail­able, or from the patient directly. Participants must be between the ages of 18 and 75. If interested in participating in the study, please contact Dr. Bijay Nair at . For more in­for­ma­tion, see the clinical trial description and results from a Phase 1 study of this ther­apy.

National Cancer Institute To Begin Phase 1 Study Of Reolysin For Multiple Myeloma – Oncolytics Biotech, the com­pany devel­op­ing the drug Reolysin, recently announced plans for a Phase 1 clin­i­cal trial investigating the effectiveness of Reolysin in re­lapsed multiple myeloma patients. Reolysin is a formulation of a common human virus that is able to infect and kill certain cancer cells, including myeloma cells. The study is sponsored by the Cancer Therapy Evaluation Program of the U.S. National Cancer Institute and is not yet recruiting participants. For more in­for­ma­tion, please see the Oncolytics press release.

Multiple Myeloma Education Programs – Two educational pro­grams for multiple myeloma patients will be held on May 21. Dr. Robert Vescio will speak at the event held in Riverside, CA, and Dr. Ruben Niesvizky will speak at the event in Albany, NY. The physicians will also answer patients’ questions. In addi­tion, a multiple myeloma patient will speak at each pro­gram. Attendees can also connect with others at the event who have been affected by myeloma. Both events are sponsored by Millennium. For more in­for­ma­tion, please see the Beacon event descriptions (Riverside, Albany). To register, call 1-866-508-6181.

For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.