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Related terms: Cancer, Malignant Plasmacytoma, Cancer, Multiple Myeloma, Cancer, Plasma Cell Dyscrasia, Cancer, Plasma Cell Myeloma, Malignant Plasmacytoma, Myeloma, Multiple, Plasma Cell Dyscrasia, Plasma Cell Myeloma, Plasmacytoma of Bone

FDA Medwatch Alert: Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold

Posted 18 days ago by Drugs.com

ISSUE: Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma. The FDA statement is based on review of data from two clinical trials (KEYNOTE-183 and KEYNOTE-185) evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. On July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with this drug, because interim results from both trials ... Read more

Related support groups: Multiple Myeloma, Keytruda, Pembrolizumab

Genmab Announces U.S. FDA Approval of Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

Posted 22 Jun 2017 by Drugs.com

Copenhagen, Denmark; June 16, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today the U.S. Food and Drug Administration (FDA) has approved the use of Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Darzalex is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize the product. Genmab will receive milestone payments totaling USD 25 million from Janssen in connection with the approval and first commercial sale of Darzalex under the newly expanded label. The sale is expected to occur quickly after the approval. The approval and related milestones do not impact the financial guidance issued by G ... Read more

Related support groups: Multiple Myeloma, Darzalex, Daratumumab

CAR T-cell Therapy May Thwart Multiple Myeloma

Posted 5 Jun 2017 by Drugs.com

MONDAY, June 5, 2017 – Genetically tuning a person's own immune cells to target cancer appears to provide long-lasting protection against a blood cancer called multiple myeloma, an early trial from China shows. The treatment, called CAR T-cell therapy, caused 33 out of 35 patients with recurring multiple myeloma to either enter full remission or experience a significant reduction in their cancer. The results are "impressive," said Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society. "These are patients who have had prior treatment and had their disease return, and 100 percent of the patients are reported to have had some form of meaningful response to these cells that were administered," Lichtenfeld said. The new therapy is custom-made for each patient. Doctors collect the patient's own T-cells – one of the immune system's main cell types – and ... Read more

Related support groups: Multiple Myeloma, Osteolytic Bone Lesions of Multiple Myeloma

FDA Expands Indication for Revlimid (lenalidomide) as a Maintenance Treatment for Patients with Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplant (auto-HSCT)

Posted 28 Feb 2017 by Drugs.com

SUMMIT, N.J.--(BUSINESS WIRE) February 22,2017 – Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for Revlimid (lenalidomide) 10 mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant (auto-HSCT). The expanded indication makes Revlimid the first and only treatment to receive FDA approval for maintenance use following auto-HSCT. "Autologous stem cell transplant after induction therapy is part of the continuum of care for transplant-eligible multiple myeloma patients. However, most patients will still see their disease recur or progress after this treatment," said Philip McCarthy, M.D., Director, Blood and Marrow Transplant Center, Department of Medicine at Roswell Park Cancer Institute. "Lenalidomide maintenance ... Read more

Related support groups: Multiple Myeloma, Revlimid, Lenalidomide

Powerful Drug for Advanced Cancers May Need Less Frequent Dosing

Posted 4 Jan 2017 by Drugs.com

WEDNESDAY, Jan. 4, 2017 – Use of a bone cancer drug once every three months, instead of monthly, does not boost the risk of bone problems over two years, a new study finds. That could reduce side effects from the drug, known as zoledronic acid (Zometa), and increase cost savings, the researchers said. The drug is used to treat the spread of breast cancer, prostate cancer and multiple myeloma to the bone. Current guidelines suggest that zoledronic acid be given intravenously every three to four weeks to reduce cancer-linked pain, as well as the risk of bone problems, such as broken bones. However, the drug comes with its own, often serious, side effects. "It can cause flu-like symptoms and bone pain in the short term," noted one oncologist, Dr. Jane Carleton. She's associate chief of clinical affairs at Northwell Health Cancer Institute in Lake Success, N.Y. According to Carleton, ... Read more

Related support groups: Cancer, Breast Cancer, Prostate Cancer, Breast Cancer, Metastatic, Reclast, Multiple Myeloma, Zometa, Aclasta, Zoledronic Acid, Osteolytic Bone Lesions of Multiple Myeloma

Darzalex (daratumumab) Approved by FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy

Posted 23 Nov 2016 by Drugs.com

HORSHAM, PA, Nov. 21, 2016 – Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.1 Clinical studies have shown that Darzalex, in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, reduced the risk of disease progression or death by 63 percent, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy (Hazard Ratio [HR]=0.37; 95 percent CI [0.27, 0.52], p Read more

Related support groups: Dexamethasone, Multiple Myeloma, Bortezomib, Lenalidomide, Darzalex, Daratumumab

Drug Trio Shows Major Promise Against Myeloma

Posted 6 Oct 2016 by Drugs.com

THURSDAY, Oct. 6, 2016 – Adding a newer drug to a standard treatment for advanced cases of multiple myeloma may significantly boost patients' chances of a response and even recovery, a new clinical trial finds. Of patients given the drug, called daratumumab, 43 percent had a complete response – meaning there were no signs of the cancer left. That compared with 19 percent of patients who received a standard drug duo alone. And over 13.5 months, the daratumumab combination cut patients' risk of dying or seeing their cancer progress by 63 percent, the study found. Researchers called the results "unprecedented" for patients like these. All had relapsed or refractory myeloma – which means the cancer had either come back or failed to respond to the previous treatment. "It is very likely that (this regimen) will be rapidly adopted by practicing physicians," said lead researcher Dr. Meletios ... Read more

Related support groups: Dexamethasone, Decadron, Multiple Myeloma, Revlimid, TobraDex, Ciprodex, Maxitrol, Ozurdex, Dexamethasone/Tobramycin, Osteolytic Bone Lesions of Multiple Myeloma, Dexamethasone/Neomycin/Polymyxin B, Maxidex, Lenalidomide, Decadron Tablets, Tobradex ST, Darzalex, Decadron Dose Pack, Dexone, Poly-Dex, Dexpak Taperpak

Superior Results for Myeloma Drug That's Added Earlier in Treatment

Posted 6 Jun 2016 by Drugs.com

MONDAY, June 6, 2016 – A recently approved immunotherapy drug for a blood cancer called multiple myeloma can provide even better benefits if patients receive it earlier in their treatment, new clinical trial results show. Darzalex (daratumumab) reduced patients' risk of cancer progression by 70 percent when added to a standard two-drug regimen for people with recurring myeloma, said lead researcher Dr. Antonio Palumbo. He is chief of the myeloma unit at the University of Torino department of oncology in Italy. The new drug essentially doubled the response that doctors expect from the standard regimen of bortezomib (another immunotherapy drug) and dexamethasone (a steroid drug). About 19 percent of patients given Darzalex had their cancer go into full remission, compared with just 9 percent of those taking the standard treatment, researchers found. "Very good" response rates doubled to ... Read more

Related support groups: Multiple Myeloma, Osteolytic Bone Lesions of Multiple Myeloma, Darzalex, Daratumumab

Exercise May Cut Risk of 13 Cancers, Study Suggests

Posted 16 May 2016 by Drugs.com

MONDAY, May 16, 2016 – Exercise may significantly reduce your risk for many types of cancer, including some of the most lethal forms of the disease, a large review suggests. Working out for even a couple of hours a week appears to shrink the risk of breast, colon and lung cancer, said researchers who looked at 1.4 million adults. "Those are three of the four major cancers that affect Americans today," said Marilie Gammon. She is a professor of epidemiology with the University of North Carolina at Chapel Hill Gillings School of Public Health. And fitness buffs, take heart – your cancer risk appears to continue to decline as you rack up hours of physical activity, with no apparent upper plateau, said study lead author Steven Moore, an investigator with the U.S. National Cancer Institute. "The more activity, the more the benefit," Moore said. "As people did more, their risk continued to ... Read more

Related support groups: Cancer, Breast Cancer, Leukemia, Lung Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, Multiple Myeloma, Endometrial Cancer, Small Cell Lung Cancer, Acute Myeloid Leukemia, Bladder Cancer, Stomach Cancer, Breast Cancer, Prevention, Head and Neck Cancer, Acute Lymphoblastic Leukemia, Gastric Cancer, Osteolytic Bone Lesions of Multiple Myeloma, Urinary Tract Cancer, Acute Myeloblastic Leukemia

FDA Medwatch Alert: BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries

Posted 16 May 2016 by Drugs.com

ISSUE: FDA is informing health care professionals that a counterfeit version of the FDA approved cancer drug, BiCNU (carmustine for injection) 100 mg, has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU. See the FDA Alert for more information, including product photos and affected lot numbers. BACKGROUND: The authentic product is approved to treat different types of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s). BiCNU is manufactured by Emcure Pharmaceuticals Ltd. and distributed in the United States by Heritage Pharmaceuticals Inc. BiCNU is available as a vial of BiCNU and dehydrated alcohol co-packaged together. While the NDC on the outer package of the authentic and counterfeit ver ... Read more

Related support groups: Brain Tumor, Multiple Myeloma, Non-Hodgkin's Lymphoma, Glioblastoma Multiforme, Hodgkin's Lymphoma, Malignant Glioma, BiCNU

Radon in the Home May Be Linked to Blood Cancers in Women

Posted 3 May 2016 by Drugs.com

TUESDAY, May 3, 2016 – New research suggests a strong link between exposure to high levels of radon in the home and women's risk of blood cancers. Radon is a naturally occurring radioactive gas, the U.S. Environmental Protection Agency says. It's known to cause lung cancer and is the second leading cause of lung cancer in the United States, the researchers said. The American Cancer Society collected information over 19 years on more than 140,000 Americans as part of a prevention study. During that time, just over 3,000 cases of blood cancer were diagnosed. The cancers included leukemia, lymphoma and myeloma, the study found. Women who lived in counties with the highest radon levels were 63 percent more likely to develop blood cancers than those in counties with the lowest radon levels. There was no link seen among men, the study noted. The study was published online recently in the ... Read more

Related support groups: Cancer, Leukemia, Lung Cancer, Non-Small Cell Lung Cancer, Lymphoma, Multiple Myeloma, Poisoning, Small Cell Lung Cancer, Toxic Reactions Incl Drug and Substance Abuse

FDA Grants Spectrum Pharmaceuticals Approval of Evomela (melphalan) for Injection

Posted 16 Mar 2016 by Drugs.com

HENDERSON, Nev., March 15, 2016 --(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted approval of Evomela for use in two indications: 1) use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM), and 2) for the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM. “I am very proud to announce that Spectrum has been able to bring another new cancer drug to the market,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pha ... Read more

Related support groups: Multiple Myeloma, Melphalan, Evomela

FDA Approves New Kyprolis (Carfilzomib) Combination Therapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Posted 21 Jan 2016 by Drugs.com

THOUSAND OAKS, Calif., Jan. 21, 2016 /PRNewswire/ – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent. "Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a ... Read more

Related support groups: Multiple Myeloma, Carfilzomib, Kyprolis

Empliciti Approved for Multiple Myeloma

Posted 1 Dec 2015 by Drugs.com

MONDAY, Nov. 30, 2015 – Empliciti (elotuzumab), in combination with two other drugs, has been approved by the U.S. Food and Drug Administration to treat the blood cancer multiple myeloma. The drug is only approved for patients who have already been given one-to-three prior therapies for the disease. Multiple myeloma is a type of cancer that affects germ-fighting white blood cells produced in bone marrow. Symptoms typically include a weakened immune system and bone and kidney problems. Nearly 27,000 new cases are projected in the United States, and more than 11,000 will die from it this year, the National Cancer Institute estimates. Empliciti directs the immune system to kill multiple myeloma cells, the FDA explained Monday in a news release. It is approved in combination with another anti-cancer drug, Revlimid (lenalidomide), and the corticosteroid dexamethasone. Empliciti was ... Read more

Related support groups: Multiple Myeloma, Empliciti, Elotuzumab

FDA Approves Empliciti (elotuzumab) for Multiple Myeloma

Posted 1 Dec 2015 by Drugs.com

November 30, 2015 – Today the U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. This disease may result in a weakened immune system, and cause other bone and kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year. “We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," said Richard P ... Read more

Related support groups: Multiple Myeloma, Empliciti, Elotuzumab

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