Articles tagged with: Darzalex
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This year’s annual meeting of the American Society of Clinical Oncology (ASCO) came to an end yesterday in Chicago.
Monday was the busiest day with regard to myeloma-related research. The day started with an oral presentation session that included eight talks about important new myeloma-related research. A poster session in the afternoon included several posters about myeloma-related research.
This article summarizes the most important findings from Monday's oral presentation session. A later article will cover the findings from the afternoon poster session.
The content in our daily updates is based on the …
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In a recent review article published in the journal Clinical Cancer Research, two myeloma experts from the Dana-Farber Cancer Institute, Dr. Nikhil Munshi and Dr. Kenneth Anderson, review the latest strategies in the treatment of multiple myeloma.
In their article, the experts discuss newer therapies that appear to be promising in clinical and preclinical studies.
According to the physicians, combination therapies that specifically target a patient’s genetic form of the disease will be required for long-term disease control and ultimately a cure.
Some Historical Perspective
In their review article, Drs. Munshi and …
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The American Society of Clinical Oncology will hold its 49th annual meeting May 31 through June 4 in Chicago.
Similar to previous years, more than 25,000 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. The theme for this year’s meeting is “Building Bridges to Conquer Cancer.”
During the meeting, there will be presentations and seminars about all areas of cancer, including many focused specifically on multiple myeloma. The ASCO website currently lists more than 60 myeloma-based presentations (included …
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Daratumumab Receives Breakthrough Therapy Designation For Multiple Myeloma – The U.S. Food and Drug Administration (FDA) last week granted breakthrough therapy designation to the investigational drug daratumumab. The breakthrough therapy designation is a new designation, signed into law in 2012. It is designed to accelerate the development and review process for drugs intended to treat serious or life-threatening illnesses. Daratumumab is being developed by the Danish biotechnology company Genmab together with Janssen Biotech, a Johnson & Johnson (NYSE: JNJ) subsidiary. It is a monoclonal antibody, like elotuzumab and siltuximab, that signals the immune system to kill myeloma cells. Results from a Phase 1/2 clinical trial indicated that daratumumab is effective in heavily pretreated myeloma patients (see related Beacon news). For more information, please see the Genmab press release.
Statins May Aid Stem Cell Collection In Multiple Myeloma – Results from a recent retrospective study indicate that statins may have a positive impact on stem cell collection in multiple myeloma patients. Specifically, the researchers found that the success rate for sufficient stem cell collection was higher in patients who received statins during stem cell collection (85 percent), compared to patients who did not receive statins (64 percent). All patients received granulocyte colony-stimulating factor (G-CSF) as a stem cell mobilizing agent. The researchers point out that larger studies are necessary to confirm their findings. Statins are drugs that lower cholesterol levels by inhibiting cholesterol production in the liver. Atorvastatin (Lipitor) is the most common statin administered to patients with heart disease. A previous study showed that statins reduce a myeloma patient’s chance of developing the complication graft-versus-host disease after undergoing a donor stem cell transplant (see related Beacon news). For more information, please refer to the study in the journal Clinical Translational Oncology (abstract).
Study Finds Bisphosphonates May Not Decrease Kidney Function In Myeloma Patients Undergoing Stem Cell Transplantation – Findings from a retrospective study show that the bisphosphonates Boniva (ibandronate), Aredia (pamidronate), and Zometa (zoledronic acid) may not significantly decrease kidney function in multiple myeloma patients undergoing stem cell transplantation. The researchers also found that the impact of each of the three bisphosphonates on kidney function were similar. Specifically, 33 percent of patients who received Boniva, 44 percent who received Aredia, and 21 percent who received Zometa experienced a decrease in creatinine clearance of at least 25 percent over the course of bisphosphonate therapy. The researchers conclude that bisphosphonate therapy for up to three years appears to be safe on kidneys. Bisphosphonates are prescribed in multiple myeloma to slow down and prevent bone destruction. Previous studies have found that bisphosphonates may cause kidney damage. For more information, please see the study in the International Journal of Hematology (abstract).
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Within the past nine months, two new agents have been approved for the treatment of relapsed multiple myeloma.
In July 2012, a second generation proteasome inhibitor, Kyprolis (carfilzomib), was approved for patients with relapsed/refractory disease. In February of this year, Pomalyst (pomalidomide) was approved for use in similar patients.
These two agents, with dexamethasone (Decadron) or in combination with other drugs, should further broaden the armamentarium for the treatment of myeloma as we continue to strive to make myeloma a chronic disease.
Rather than dwell on …
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FDA Puts Daratumumab On Fast Track For Treatment Of Multiple Myeloma – The U.S. Food and Drug Administration (FDA) last week granted fast track designation to the investigational drug daratumumab. The fast track designation accelerates the development and review process for drugs intended to treat serious or life-threatening illnesses. Daratumumab is being developed by the Danish biotechnology company Genmab together with Janssen Biotech, a Johnson & Johnson (NYSE: JNJ) subsidiary. It is a monoclonal antibody, like elotuzumab and siltuximab, that signals the immune system to kill myeloma cells. Results from a phase 1/2 clinical trial indicated that daratumumab is effective in heavily pretreated myeloma patients (see related Beacon news). For more information, please see the Genmab press release.
Mayo Clinic Researchers Update Guidelines For Treatment Of Newly Diagnosed Myeloma – Researchers from the Mayo Clinic have updated their guidelines for the treatment of newly diagnosed multiple myeloma patients. The guidelines, called The Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART), were first developed in 2007 and last updated in 2009. Based on research findings released since 2009, the researchers have added six major updates to the previous version of mSMART. One significant update was the addition of an intermediate-risk classification to the existing high-risk and standard-risk classifications. The researchers also note that there may be more benefit to delaying stem cell transplants in myeloma patients, due to improved induction therapies and stem cell collection procedures. The updated guidelines also recommend that maintenance therapy be considered, but not mandated, as a treatment option for patients who have undergone a stem cell transplant. For more information, please see the 2013 mSMART Guidelines.
Sensory Deficits Prior To Treatment May Predict Risk Of Peripheral Neuropathy In Myeloma Patients – Results from a recent study indicate that preexisting sensory deficits in multiple myeloma patients increase a patient’s risk of developing peripheral neuropathy (pain, tingling, and loss of sensation in the extremities due to nerve damage) following treatment for myeloma. Specifically, the researchers found that patients with sensory deficits before the start of treatment were at a higher risk of developing treatment-induced peripheral neuropathy. Treatment-induced peripheral neuropathy is a common complication for myeloma patients who undergo treatment with Velcade (bortezomib) or thalidomide (Thalomid). The researchers believe that testing of nerve function prior to treatment may be able to identify patients at high risk of developing treatment-induced peripheral neuropathy. For more information, please refer to the study in Cancer Chemotherapy and Pharmacology (abstract).
Phase 1/2 Clinical Trial Of Elotuzumab Plus Revlimid, Velcade, And Dexamethasone In Newly Diagnosed High-Risk Myeloma Patients Has Launched – The Southwest Oncology Group, in collaboration with the National Cancer Institute and pharmaceutical company Bristol-Myers Squibb, has started a Phase 1/2 clinical trial of elotuzumab in combination with Velcade, Revlimid (lenalidomide), and dexamethasone (Decadron). The study is open to newly diagnosed high-risk myeloma patients. Elotuzumab, which is being developed by Bristol-Myers Squibb (NYSE: BMY), is a monoclonal antibody that stimulates the immune system to destroy myeloma cells. Previous studies have shown that it is effective in relapsed and refractory myeloma patients, particularly when used in combination with Revlimid and dexamethasone (see related Beacon news). About half the patients in the new trial will be treated with Velcade, Revlimid, and dexamethasone alone. The other half will receive the same three drugs plus elotuzumab. For more information about the study, including how to enroll, please see the clinical trial description.
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Looking back at all that has happened in the world of multiple myeloma since January of 2012, it is hard not to be impressed by the many important developments that took place.
There is the obvious fact that, during that time, not one, but two new drugs to treat myeloma were approved by the U.S. Food and Drug Administration (FDA). Prior to 2012, the FDA had not approved a novel anti-myeloma therapy in over six years.
Yet 2012 was meaningful to the myeloma community for reasons beyond the activity at the FDA’s …