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Posted May 17, 2012

Awards to advance regenerative medicine address diverse, debilitating diseases and conditions

COLUMBIA, Md. – The Maryland Stem Cell Research Commissionhas completed its review of the 179 applications received in response to its three FY 2012 Requests for Applications (RFAs). The board of directors of the Maryland Technology Development Corporation (TEDCO) approved the Commission’s recommendation to fund 40 new proposals with the Maryland Stem Cell Research Fund’s (MSCRF) $12.4 million FY 2012 budget.

“We are pleased to announce our grant awards for FY 2012,” said Margaret Conn Himelfarb, MPH, chair of the Commission. “These projects address a diverse array of debilitating and costly diseases and conditions, some of which are traditionally underfunded. Maryland’s investment in cutting-edge stem cell research continues to advance the field and strengthens our State’s national leadership position in the life sciences. We are grateful to Governor Martin O’Malley and the Maryland General Assembly for recognizing the tremendous economic and humanitarian benefits of this pioneering research.”

This funding cycle, the Commission gave priority to proposals that focus on advancing regenerative medicine by selecting promising research that targets sickle cell anemia, schizophrenia, type 1 diabetes, nerve injury, Parkinson’s disease, Crohn’s disease, multiple sclerosis (MS), heart disease, osteoarthritis, Lou Gehrig’s disease (ALS), retinal disease, and other debilitating medical conditions. Continuing the collaboration initiated last year with the California Institute of Regenerative Medicine (CIRM), the MSCRF will also support a Maryland researcher working with CIRM-funded scientists to study stem cell differentiation and bone repair.

This year’s MSCRF awards include:

9 Investigator-Initiated Research Grants (RFA-MD-12-1) – providing up to $600,000 in direct costs over a maximum of three years to investigators with preliminary data to support their hypotheses.

17 Exploratory Research Grants (RFA-MD-12-2) – providing up to $200,000 in direct costs over a maximum of two years to researchers with novel approaches, mechanisms or models that may differ from current thinking in the field and/or new hypotheses that have little or no preliminary data.

14 Post-Doctoral Fellowship Research Grants (RFA-MD-12-3) – providing post-doctoral fellows up to $55,000 per year, for up to two years.

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Maryland Stem Cell Research Commission Funds 40 New Proposals in FY 2012

IRVINE, Calif.–(BUSINESS WIRE)–

California Stem Cell, Inc. (CSC) announced today that well-known stem cell & regenerative medicine industry veteran Gregory A. Bonfiglio, J.D. has joined its Board of Directors.

Gregory Bonfiglio has over 25 years of experience working with technology companies, and was an early investor in the stem cell industry. He is Managing Partner of Proteus Venture Partners, an investment & advisory firm he founded in early 2006 to provide venture funding and strategic advisory services in the stem cell & regenerative medicine space. Mr. Bonfiglio is on the Boards of VistaGen Therapeutics and StemCyte, Inc.; he is the Chairman of the Board of the Centre for Commercialization of Regenerative Medicine (RM Translation Center in Toronto, Canada). In addition, Mr. Bonfiglio sits on the Advisory Board and Finance Committee of the International Society for Stem Cell Research (ISSCR); he is on the Commercialization Committee of the International Society for Cellular Therapy (ISCT).

Mr. Bonfiglio brings to CSC an extensive background in strategic consulting, having held partnership positions with various legal and venture firms, and having successfully led a team that took pioneering stem cell company Advanced Cell Technology public in early 2005. Were thrilled to welcome to our board someone with the breadth of industry experience that Greg has, and are very much looking forward to his participation in the continued growth of this Company, said COO Chris Airriess.

This appointment coincides with a ramp up of commercial product sales as well as advancements of CSCs active Phase II clinical trial in metastatic melanoma.

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company which has developed proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

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Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors

Stocks go up, stocks go down — and so do analysts’ opinions of them. This series, brought to you by Yahoo! Finance, looks at which upgrades and downgrades make sense, and which ones investors should act on. This morning, Wall Street was feeling mighty optimistic, so we’ll be examining the new buy ratings that have just come out on Dunkin’ Brands (DNKN – News), SandRidge Energy (SD – News), and finally, Aastrom Biosciences (ASTM – News).

And we’re off!Attacking these ratings in first (worst) order, we begin with Aastrom Biosciences, a pioneer in the field of stem cell research. This morning, Aastrom got a buy rating from the folks at Ascendiant Capital. With a name like “Ascendiant,” you’d expect these analysts to be an optimistic bunch, and you’d be right. Because Ascendiant didn’t just give Aastrom any old buy rating, but a strong buy, and a $4.25 price target that values the stock at nearly twice its current market cap.

Why? According to StreetInsider.com, Ascendiant is picking Aastrom primarily out of faith in its “key product, ixmyelocel-T … an autologous, bone marrow-derived cell therapy product being developed for the treatment of critical limb ischemia (CLI) and dilated cardiomyopathy (DCM).” The therapies are currently undergoing Phase 3 and Phase 2 trials before the FDA, respectively. If they succeed, the days of people like me mocking Aastrom as a profitless, near-revenueless R&D shop will be at an end.

So let’s get while the getting is good: So far, Aastrom has no profits. Its revenues over the past 12 months were a mere $11,000 — and no, I didn’t misplace a decimal. 11K, period. So while it’s possible Ascendiant is right about Aastrom, that its drugs will be blockbusters and the stock is a resounding success, for now the jury is out. Buying shares of this company isn’t investing. It’s speculation, pure and simple.

Less quicksand at SandRidgeSomewhat better is the news at natural gas developer SandRidge Energy, which this morning received a more muted upgrade to hold. Canaccord Genuity is the analyst behind this one, and according to Canaccord, the reason to consider holding onto SandRidge today is basically because the analyst’s previous recommendation (sell) has played out as predicted. With nat gas prices still depressed, SandRidge’s stock price is down 30% since February, leaving “minimal downside” left in the stock.

What debate there remains, it would appear, is over whether SandRidge can reach free-cash-flow-breakeven (i.e., generate enough cash flow to pay for the investments it must make in its business) by 2014. SandRidge says it can. Canaccord says it can’t, and will likely keep on “outspending cash flow by $1+ billion per annum for the foreseeable future.”

With $2.7 billion in net debt already, that prospect would be bad news for SandRidge if it turns out Canaccord is right. On the other hand, if SandRidge knows its business better than the analyst does — or if nat gas prices rebound to more historically normal levels — the stock could turn around in a jiffy. In this context, a “hold until believed” stance on SandRidge seems appropriate.

And the first comes lastAnd finally, we come to a more familiar name — because after all, America runs on Dunkin’. The shares are also taking a bit of a jog (up) this morning after being upgraded to buy by analysts at Argus. According to Argus, “solid domestic and international growth opportunities” argue in favor of jumping into Dunkin’ today.

Investors had better hope Argus is right about that, though, because elsewhere on Wall Street, the consensus is that Dunkin’ will be lucky to achieve 16% long-term growth over the next five years. For a stock that costs 31 times free cash flow today, and 63 times earnings, that’s probably not going to be solid enough to support the stock price.

In the end, if you’re looking for a great stock at a bargain price… Dunkin’ Brands probably isn’t it. Time to bake some better investment ideas, Argus.

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Wednesday's Top Upgrades (and Downgrades)

SAN DIEGO, May 16, 2012 /PRNewswire/ — Optimer Pharmaceuticals, Inc. (OPTR) today announced the results of a retrospective subpopulation analysis of 183 patients with cancer from the company’s two large Phase 3 trials, which showed the cancer patients with Clostridium difficile-associated diarrhea (CDAD) who were treated with DIFICID (fidaxomicin) tablets experienced resolution of their diarrheal symptoms approximately two days faster than those treated with oral vancomycin. These results will be presented on June 2nd at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

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“CDAD is a serious complication for cancer patients and potentially can disrupt the effects of cancer treatment and result in dehydration, impaired functioning, fatigue and, in severe cases, death,” said Kathleen Mullane, D.O., Associate Professor of Medicine, Section of Infectious Diseases and Global Health, at the University of Chicago. “The results of this analysis indicate DIFICID may provide faster resolution of diarrhea when compared to vancomycin in a subset of cancer patients. While further studies are needed to confirm these findings, the results suggest the drug may serve as an important treatment option for this population and others at heightened risk for CDAD.”

The analysis assessed treatment outcomes between patients with active cancer and patients without cancer who were treated with either DIFICID or oral vancomycin in two large, pivotal, Phase 3 studies. Results showed that overall, cancer patients with CDAD had slower time to resolution of diarrhea (TTROD) than non-cancer patients (100 hours vs. 55 hours, respectively; K-M log rank p<0.001). However, when treatment outcomes were compared between cancer patients receiving DIFICID or oral vancomcyin, patients treated with DIFICID experienced resolution of diarrhea two days faster than those treated with vancomycin (74 hours vs. 123 hours, respectively; K-M log rank p=0.045). The overall safety profile was similar between the DIFICID and vancomycin treatment groups.

“Fast resolution of diarrhea is critically important for patients undergoing cancer treatment to help resume focus on their primary cancer treatment as quickly as possible,” said Sherwood L. Gorbach, M.D., Chief Scientific Officer and Senior Vice President of Optimer Pharmaceuticals, Inc. “These results further support the strong efficacy profile of DIFICID.”

Additional results from the retrospective subpopulation analysis that demonstrate the effectiveness of DIFICID in treating CDAD in cancer patients recently were presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). These results showed that DIFICID was five times more likely than vancomycin to produce a clinical response and three times more likely to lead to a sustained response, while patients treated with vancomycin had a 2.6 fold greater risk of experiencing recurrence. Specifically, DIFICID provided superior response compared to vancomycin across all clinical endpoints studied: clinical response (97.3% vs. 87.5%, 95% CI 1.07-23.98; p=0.041), sustained response (83.6% vs. 61.3%, 95% CI 1.50-6.91; p=0.003) and disease recurrence (14.1% vs. 30.0%, 95% CI 0.16-0.89; p=0.025).

Infections caused by C. difficile and the resulting CDAD pose a significant threat to cancer patients, primarily those with compromised immune systems due to chemotherapy or stem cell transplants. Cancer patients also are at risk for CDAD due to prolonged hospitalization and exposure to antibiotics. In fact, cancer patients with solid tumor or hematologic malignancies account for 16% of hospital CDAD cases.

About the Study

The results are based on two randomized, double-blind, non-inferiority Phase 3 trials conducted at sites in North America and Europe. Subjects with confirmed CDAD received either 200 mg DIFICID (fidaxomicin) dosed orally twice daily or 125 mg vancomycin dosed orally four times daily for 10 days. The primary objective of the trials was to compare the safety and efficacy of a 10-day course of DIFICID versus a 10-day course of vancomycin for the treatment of CDAD in adults. These studies served as the basis of approval for DIFICID by the U.S. Food and Drug Administration (FDA) in May 2011.

The subpopulation analysis evaluated the treatment of 183 CDAD patients with active cancer compared to 922 CDAD patients without cancer who were among the modified intent to treat population of the Phase 3 studies (N=1105). To be included in the analysis, patients must have had a current diagnosis of cancer at the time of CDAD diagnosis and were receiving various forms of treatment. Patients with active cancer (solid tumor or hematologic malignancy) were identified from medical history, concomitant medication indications, and adverse event entries in the case report forms. The analysis assessed the number of unformed bowel movements (UBM) per 24 hours to determine time to resolution of diarrhea (TTROD) defined as the duration of passing UBMs following initial treatment, with an active response considered as <3 UBM/24 hours. TTROD was defined as hours from first dose of treatment to last UBM on the day preceding two days of <3 UBM/24 hours.

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Analysis of Data from Two Phase 3 Studies Shows DIFICID® Offered Faster Diarrheal Symptom Improvement than Oral …

NEWARK, Calif., May 17, 2012 (GLOBE NEWSWIRE) — StemCells, Inc. (Nasdaq:STEM – News) today announced completion of the first planned interim safety review of the Company’s Phase I/II spinal cord injury clinical trial, which indicated that the surgery, immunosuppression and the cell transplants have been well-tolerated. The trial, which is designed to evaluate the safety and preliminary efficacy of the Company’s proprietary HuCNS-SC(R) cells (purified human neural stem cells), represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. A summary of the data will be presented by Armin Curt, M.D., principal investigator for the clinical trial, at the Interdependence 2012 Global SCI Conference, which is being held in Vancouver, British Columbia, from May 15 to 17, 2012.

The interim data is from the first cohort of patients, all of whom suffered a complete spinal cord injury in which there is no neurological function below the level of the injury. All patients enrolled were transplanted with a dose of 20 million cells at the site of injury in the thoracic spinal cord. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically stable through the first four months following transplantation of the cells. Changes in sensitivity to touch were observed in two of the patients. The data from multiple evaluations of the patients during this four month period have been reviewed by an independent Data Safety Monitoring Committee, which has recommended that the study advance to enrollment of patients with incomplete neurological injury. Enrollment is now underway and is open to patients in Europe, the United States and Canada with incomplete spinal cord injury. The trial, which is being conducted at Balgrist University Hospital, Zurich, Switzerland, is the only ongoing clinical trial evaluating neural stem cell transplantation in spinal cord injury.

“We are very encouraged by the interim safety outcomes for the first cohort,” said Dr. Curt, who is Professor and Chairman of the Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at Balgrist University Hospital. “The patients in the trial are being closely monitored and undergo frequent clinical examinations, radiological assessments by MRI and sophisticated electrophysiology testing of spinal cord function. The comprehensive battery of tests provides important safety data and is very reassuring as we progress to the next stage of the trial.”

The Interdependence 2012 Global SCI Conference is intended to bring together international healthcare and research facilities to showcase their work through presentations, workshops and exhibits and to discuss how to advance research, implement new best practices and shape the next generation of spinal cord injury research. Interdependence 2012 is jointly organized by the Rick Hansen Institute, a Canadian not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries, and the Rick Hansen Foundation.

About the Spinal Cord Injury Clinical Trial

The Phase I/II clinical trial of StemCells, Inc.’s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The Company has dosed the first three patients all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function. The injuries are classified according to the American Spinal Injury Association Impairment Scale (AIS). In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.

All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and a separate four-year observational study will be initiated at the conclusion of this trial.

The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at stemcells.pz@balgrist.ch.

Additional information about the Company’s spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.

About Balgrist University Hospital

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StemCells, Inc. Reports Positive Interim Safety Data From Spinal Cord Injury Trial

Breast cancer stem cells wear a cell surface protein that is part nametag and part bull’s eye, identifying them as potent tumor-generating cells and flagging their vulnerability to a drug, researchers at The University of Texas MD Anderson Cancer Center report online in Journal of Clinical Investigation.

“We’ve discovered the first single marker for breast cancer stem cells and also found that it’s targetable with a small molecule drug that inhibits an enzyme crucial to its synthesis,” said co-senior author Michael Andreeff, M.D., Ph.D., professor in MD Anderson’s Departments of Leukemia and Stem Cell Transplantation and Cellular Therapy.

Andreeff and colleagues are refining the drug as a potential targeted therapy for breast cancer stem cells, which are thought to be crucial to therapy resistance, disease progression and spread to other organs.

“It’s been difficult to identify cancer stem cells in solid tumors,” Andreeff said. “And nobody has managed to target these cells very well.”

The marker is the cell surface protein ganglioside GD2. The drug is triptolide, an experimental drug that Andreeff has used in preclinical leukemia research. The team found triptolide blocks expression of GD3 synthase, which is essential to GD2production.

Triptolide stymied cancer growth in cell line experiments and resulted in smaller tumors and prolonged survival in mouse experiments. Drug development for human trials probably will take several years.

Cancer stem cells are similar to normal stem cells

Research in several types of cancer has shown cancer stem cells are a small subpopulation of cancer cells that are capable of long-term self-renewal and generation of new tumors. More recent research shows they resist treatment and promote metastasis.

Cancer stem cells are similar to normal stem cells that renew specialized tissues. The breast cancer findings grew out of Andreeff’s long-term research in mesenchymal stem cells, which can divide into one copy of themselves and one differentiated copy of a bone, muscle, fat or cartilage cell.

Andreeff has shown these mobile mesenchymal stem cells home to wounds, including tumors, making them potential carriers of cancer therapy.

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Breast cancer cell surface protein blows cover of potent tumor-generating cells

Cell surface protein blows potent cells cover; targeted drug works in preclinical tests

Newswise HOUSTON Breast cancer stem cells wear a cell surface protein that is part nametag and part bulls eye, identifying them as potent tumor-generating cells and flagging their vulnerability to a drug, researchers at The University of Texas MD Anderson Cancer Center report online in Journal of Clinical Investigation.

Weve discovered a single marker for breast cancer stem cells and also found that its targetable with a small molecule drug that inhibits an enzyme crucial to its synthesis, said co-senior author Michael Andreeff, M.D., Ph.D., professor in MD Andersons Departments of Leukemia and Stem Cell Transplantation and Cellular Therapy.

Andreeff and colleagues are refining the drug as a potential targeted therapy for breast cancer stem cells, which are thought to be crucial to therapy resistance, disease progression and spread to other organs.

Its been difficult to identify cancer stem cells in solid tumors, Andreeff said. And nobody has managed to target these cells very well.

The marker is the cell surface protein ganglioside GD2. The drug is triptolide, an experimental drug that Andreeff has used in preclinical leukemia research. The team found triptolide blocks expression of GD3 synthase, which is essential to GD2production.

Triptolide stymied cancer growth in cell line experiments and resulted in smaller tumors and prolonged survival in mouse experiments. Drug development for human trials probably will take several years.

Cancer stem cells are similar to normal stem cells

Research in several types of cancer has shown cancer stem cells are a small subpopulation of cancer cells that are capable of long-term self-renewal and generation of new tumors. More recent research shows they resist treatment and promote metastasis.

Cancer stem cells are similar to normal stem cells that renew specialized tissues. The breast cancer findings grew out of Andreeffs long-term research in mesenchymal stem cells, which can divide into one copy of themselves and one differentiated copy of a bone, muscle, fat or cartilage cell.

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Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid-, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute.

The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy.

“These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients,” said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study’s co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. “We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won’t come back and worsen.”

These data were supported by similar Phase III studies reported from France and Italy in the same issue of the New England Jounal of Medicine demonstrating that maintenance therapy after stem cell transplantation was associated with improved disease control.

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Lenalidomide following stem cell transplant can halt progression of blood cancer

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QualityStocks News – International Stem Cell Scientists to Present Pre-Clinical Research Results at Gene and Cell …

Public release date: 15-May-2012 [ | E-mail | Share ]

Contact: Elisa Williams willieli@ohsu.edu 503-494-4530 Oregon Health & Science University

PORTLAND, Ore. Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute.

The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy.

“These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients,” said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study’s co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. “We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won’t come back and worsen.”

These data were supported by similar Phase III studies reported from France and Italy in the same issue of the New England Jounal of Medicine demonstrating that maintenance therapy after stem cell transplantation was associated with improved disease control.

Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell normally responsible for producing antibodies. In patients impacted by multiple myeloma, collections of abnormal plasma cells accumulate in the bone marrow, interfering with the production of normal blood cells. The study focused on patients who received an autologous hematopoietic cell transplant (AHCT). AHCT procedures use patients’ own blood stem cells.

While lenalidomide increased a patient’s ability to stave off progression of the disease, questions remain regarding future approaches recognizing that quality of life measurements were not incorporated within these studies, that long-term safety issues remain unclear as there was a small but discernable risk of second cancers observed in the treated patients. In addition to the need for that cost-benefit analysis, a comparison remains to be performed with other emerging myeloma maintenance therapies.

This Phase III study of lenalidomide was conducted at 47 medical centers and involved 568 patients. It was sponsored by the National Cancer Institute (NCI). Revlimid’s manufacturer, Celgene Corp., provided the NCI with lenalidomide for this research.

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Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant