Articles tagged with: CD38 Targeted Therapies
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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 …
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HHV-6 Infection May Be Common After Stem Cell Transplantation – Results of a retrospective Israeli study indicate that human herpesvirus 6 (HHV-6) infection is common in multiple myeloma patients after own (autologous) stem cell transplantation. HHV-6 is a family of two viruses that are present, but inactive, in most adults. If the virus becomes active in an adult, the resulting infection can cause pneumonia, suppression of blood cell production, and inflammation of the brain. The Israeli researchers found that 16 percent of patients in their study developed an HHV-6 infection after stem cell transplantation. The rate of infection was higher in patients who had received initial therapy with Velcade (bortezomib) and dexamethasone (Decadron) (20 percent) compared to those who received thalidomide (Thalomid) and dexamethasone (10 percent). The researchers recommend further studies to determine if Velcade plays a role in the development infection due to the virus. For more information, please see the study in the journal Bone Marrow Research (full text).
Iron Supplementation May Increase Velcade’s Efficacy – Results of a small Italian preclinical study show that iron supplementation may increase the efficacy of Velcade. The Italian researchers found that iron supplementation promoted protein oxidation and increased myeloma cell death. They concluded that modification of the iron status in multiple myeloma patients may be worth considering to improve the efficacy of proteasome inhibitors such as Velcade. For more information, please see the study in Haematologica (full text).
Phase 1 Clinical Trial To Study SAR650984 Plus Revlimid In Previously-Treated Myeloma Patients – The pharmaceutical company Sanofi-Aventis is starting a Phase 1 trial of SAR650984 in combination with Revlimid (lenalidomide) and dexamethasone in relapsed and refractory multiple myeloma patients. Myeloma patients must have received at least two prior therapies to be able to participate in the trial. SAR650984 belongs to the same class of drugs as elotuzumab and daratumumab, called monoclonal antibodies. Monoclonal antibodies work by identifying proteins on the surface of myeloma cells and signaling for the immune system to destroy the cancer cells. For more information, including trial locations, please see the clinical trial description.
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Daratumumab continues to show promise for relapsed and refractory multiple myeloma patients. Results from a Phase 1/2 study indicate that daratumumab may be effective and safe in heavily pretreated patients.
In particular, daratumumab's activity as an anti-myeloma agent seems at least as good as that of the newest myeloma therapies.
“The response to daratumumab was accompanied by the clearance of myeloma cells,” said Dr. Torben Plesner from the Vejle Hospital in Denmark, who presented the findings from the daratumumab trial at the 2012 American Society of Hematology (ASH) meeting last month.
“Daratumumab …
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This year’s meeting of the American Society of Hematology (ASH) was held December 8 through 11 in Atlanta.
During the meeting, The Beacon published daily updates that provided overviews of the important multiple myeloma findings presented during the meeting. After the meeting concluded, The Beacon began publishing in-depth articles about the key research findings.
This article, however, shifts the focus to the bigger picture: What were the key findings of the meeting? Were there results with immediate implications for the treatment of multiple myeloma? Did the research …
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This year’s American Society of Hematology (ASH) annual meeting, which is being held in Atlanta, began yesterday and goes through Tuesday.
Today’s myeloma-related presentations began this afternoon with three sessions of oral presentations. Two of the sessions focused on results from clinical trials, most of which studied drugs that are still under development as potential treatments for multiple myeloma. The third session, which focused on the biology of myeloma, ran simultaneously with one of the sessions about clinical trial results.
This article will summarize the first oral session about multiple myeloma treatments, …
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During the upcoming annual meeting of the American Society of Hematology (ASH), which will be held December 8 through 11 in Atlanta, results will be presented from clinical trials involving a number of potential new drugs under development for the treatment of multiple myeloma.
In particular, results for newer, lesser known agents that are in the early stages of clinical development will take center stage. These agents include ARRY-520 (filanesib), BHQ880, circularly permuted TRAIL, daratumumab, dinaciclib, lorvotuzumab mertansine, oprozomib, and tabalumab.
According to the recently …
