Background
We previously showed that consolidation therapy with thalidomide and prednisolone improved progression-free and overall survival in patients with multiple myeloma who had undergone autologous stem-cell transplantation. We aimed to assess whether these survival advantages were durable at 5 years.
The ALLG MM6 trial was a multicentre, open-label, randomised phase 3 trial done between Jan 13, 2002, and March 15, 2005, at 29 sites in Australia and New Zealand. Patients with newly diagnosed multiple myeloma were randomly assigned (1:1), via computer-generated randomisation charts, to receive indefinite prednisolone maintenance alone (control group) or in combination with 12 months of thalidomide consolidation (thalidomide group) after autologous stem-cell transplantation. Randomisation was stratified by treating centre and pre-transplantation concentrations of 2 microglobulin. Patients and treating physicians were not masked to treatment allocation. Primary endpoints were progression-free survival and overall survival. Analysis was by intention to treat. Secondary endpoints were overall response to salvage therapy, incidence of second primary malignancy incidence, and cost-effectiveness. This trial is registered with the Australian and New Zealand Clinical Trials Registry, number ACTRN12607000382471.
We randomly assigned 269 patients to the thalidomide (n=114) or control group (n=129). After a median follow-up of 54 years (IQR 3172), estimated 5-year progression-free survival was 27% (95% CI 2332) in the thalidomide group and 15% (1118) in the control group (hazard ratio [HR] 016, 95% CI 0044058; p=00054) and 5-year overall survival was 66% (95% CI 6170) and 47% (4251), respectively (HR 012, 95% CI 0028056; p=00072). There was no difference in overall response to salvage therapy, survival post-progression, or incidence of secondary malignancies between the two groups. Incremental cost-effectiveness ratio was AUS$26996 per mean life-year gained.
Consolidation therapy with thalidomide and prednisolone after autologous stem-cell transplantaion is an acceptable therapeutic approach when alternative drugs are not available.
Pharmion Corporation, Novartis Pharmaceuticals, Amgen Australia, The Merrin Foundation, and Alfred Health.
Original post:
- Exercise Helps Heart Disease Patients Live Longer - November 8th, 2009 [November 8th, 2009]
- If You Have A Heart Attack, Dial 911, Don't Drive To The ER - November 8th, 2009 [November 8th, 2009]
- Dried Plums, Tart Cherries, Grapes- What do they have in common? - November 8th, 2009 [November 8th, 2009]
- Vitamin D for Me! - November 8th, 2009 [November 8th, 2009]
- Bangkok Hospital Named Best Global Hospital - November 8th, 2009 [November 8th, 2009]
- 10 Years of Stem Cell Science? Where's the Beef? - November 8th, 2009 [November 8th, 2009]
- Women Underestimate Heart Disease Risks - November 8th, 2009 [November 8th, 2009]
- A Stem Cell First- New Organ Created and Transplanted Using Adult Stem Cells - November 8th, 2009 [November 8th, 2009]
- Stem Cells Injected Directly Into the Heart- Sounds Familiar - November 8th, 2009 [November 8th, 2009]
- Heart Disease and Depression Are Linked - November 8th, 2009 [November 8th, 2009]
- TheraVitae Wishes Everyone A Happy Thanksgiving - November 8th, 2009 [November 8th, 2009]
- VesCell Adult Stem Cells Helping Pulmonary Hypertension - November 8th, 2009 [November 8th, 2009]
- VesCell Adult Stem Cells Help Dilated Cardiomyopathy Patient - November 8th, 2009 [November 8th, 2009]
- Another Dilated Cardiomyopathy Patient Helped by VesCell Adult Stem Cells - November 8th, 2009 [November 8th, 2009]
- Clinical Data of VesCell Used On Heart Disease Patients - November 8th, 2009 [November 8th, 2009]
- Results of Patients Treated with Adult Stem Cells for Heart Disease - November 8th, 2009 [November 8th, 2009]
- Results of Doctor Using VesCell for Heart Disease Published in Medical Journal - November 8th, 2009 [November 8th, 2009]
- Stem Cells from VesCell Help Another Patient With Congestive Heart Failure - November 8th, 2009 [November 8th, 2009]
- VesCell Uses Adult Stem Cells Not Fetal Stem Cells - November 8th, 2009 [November 8th, 2009]
- Dilated Cardiomyopathy Continues Improving After Stem Cell Therapy - November 8th, 2009 [November 8th, 2009]
- American Doctors Form Group to Oppose FDA's Stance On Adult Stem Cells - November 8th, 2009 [November 8th, 2009]
- Adult Stem Cell Pioneer Passes Away - November 8th, 2009 [November 8th, 2009]
- Dilated Cardiomyopathy Patient Celebrates His 1 Year Stem Cell Treatment Anniversary - November 8th, 2009 [November 8th, 2009]
- Vescell Featured In Forbes Magazine! - November 8th, 2009 [November 8th, 2009]
- Adult Stem Cells Repair Damaged Heart Muscle - November 8th, 2009 [November 8th, 2009]
- No Scooter Needed for Schlueter- Heart Disease Patient Back in Gym After Stem Cell Treatment - November 8th, 2009 [November 8th, 2009]
- Stem cells provide second chance - November 8th, 2009 [November 8th, 2009]
- Adult Stem Cell Therapy Scientific Advisory Board - November 8th, 2009 [November 8th, 2009]
- Partner hospitals give Heart Disease treatment with Adult Stem Cell Therapy - November 8th, 2009 [November 8th, 2009]
- Stem Cell Treating Physicians for Heart Disease - Vescell by Theravitae - November 8th, 2009 [November 8th, 2009]
- Heart Disease Treatment FAQs - Adult Stem Cells Treats Heart Disease - November 8th, 2009 [November 8th, 2009]
- Checklist of 12 Must-Ask Questions for Overseas Treatment - November 8th, 2009 [November 8th, 2009]
- Health teaching for patients with heart disease | VesCell adult stem cell therapy - November 8th, 2009 [November 8th, 2009]
- Ethical Debates Adult Stem Cell Research | VesCell adult stem cells treatment - November 8th, 2009 [November 8th, 2009]
- Heart disease and health policy and nurse | VesCell adult stem cells treatment - November 8th, 2009 [November 8th, 2009]
- After Stent Symptoms | VesCell Adult Stem Cell Therapy - November 8th, 2009 [November 8th, 2009]
- What is adult stem cell research | VesCell Adult Stem Cell Therapy - November 8th, 2009 [November 8th, 2009]
- Alternative Medicine for Coronary Artery Disease | VesCell Adult Stem Cell Therapy - November 8th, 2009 [November 8th, 2009]
- Diabetic, Seven Heart Attack Patient Experiences on Adult Stem Cell Treatment - November 8th, 2009 [November 8th, 2009]
- Congestive Heart Failure and Life Expectancy | VesCell Adult Stem Cell Therapy - November 8th, 2009 [November 8th, 2009]
- Chest Pain After Angioplasty with Stent | VesCell adult stem cells treatment - November 8th, 2009 [November 8th, 2009]
- Use of Stem Cells for Heart Repair | VesCell Adult Stem Cell Therapy - November 8th, 2009 [November 8th, 2009]
- Women health heart attack - November 8th, 2009 [November 8th, 2009]
- Health Facts on the Heart | VesCell Adult Stem Cells Treatment - November 8th, 2009 [November 8th, 2009]
- The Process of Stem Cells | VesCell Adult Stem Cells Treatment - November 8th, 2009 [November 8th, 2009]
- Rest Pain Leg | VesCell adult stem cells for peripheral artery disease - November 8th, 2009 [November 8th, 2009]
- Health Supplements Heart Diabetes | VesCell Adult Stem Cells Treatment - November 8th, 2009 [November 8th, 2009]
- Heart Failure Epidemic | VesCell adult stem cells treatment - November 8th, 2009 [November 8th, 2009]
- Heart Muscle Health Aspects | VesCell adult stem cell therapy - November 8th, 2009 [November 8th, 2009]
- adult stem cells | VesCell adult stem cells treatment - November 8th, 2009 [November 8th, 2009]
- Updated article about adult stem cells therapy, VesCell, as featured in Forbes Magazine - November 8th, 2009 [November 8th, 2009]
- Forbes: Vescell Stem Cell Therapy Saves Heart Failure Patient - November 8th, 2009 [November 8th, 2009]
- Foetal Stem Cells Offer Hope for Stroke Victims - November 8th, 2009 [November 8th, 2009]
- Stem cells could spell end for diabetes jabs - November 8th, 2009 [November 8th, 2009]
- Full text answers about stem cell research - November 8th, 2009 [November 8th, 2009]
- Stem Cell Transplant from Umbilical Cord Blood Is The Only Hope for SCID Sufferer - November 8th, 2009 [November 8th, 2009]
- New Studies About Umbilical Cord Blood And Children With Diabetes - November 8th, 2009 [November 8th, 2009]
- Engineered Blood Vessels Function Like Native Tissu - November 8th, 2009 [November 8th, 2009]
- Umbilical Cord Blood Stem Cells Provide Hope for Life Threatening Diseases - November 8th, 2009 [November 8th, 2009]
- Gov. Schwarzenegger Signs SB962 to Create a System to Collect and Store Umbilical Cord Blood - November 8th, 2009 [November 8th, 2009]
- Baby Boy Treated for Cerebral Palsey with His Own Cord Blood Stem Cells - November 8th, 2009 [November 8th, 2009]
- Cord Blood May Preserve Insulin Production in Newly Diagnosed Children With Type 1 Diabetes - November 8th, 2009 [November 8th, 2009]
- A "Holy Grail" Of Healing, CBS Evening News - November 8th, 2009 [November 8th, 2009]
- After Receiving Unusual Stem Cell Transplant, Coppell Toddler Comes Home from Hospital - November 8th, 2009 [November 8th, 2009]
- Stem Cell Hope for Bone Fractures - November 8th, 2009 [November 8th, 2009]
- Cord Blood Stem Cells And Cardiovascular Disease - November 8th, 2009 [November 8th, 2009]
- Creating a Cord-Blood Lifeline - November 8th, 2009 [November 8th, 2009]
- Saving Cord Blood - November 8th, 2009 [November 8th, 2009]
- Stem Cell Implant to the Brain Helps Improve Parkinson's Symptoms: Presented at SIR - November 8th, 2009 [November 8th, 2009]
- Governor Rendell Signs Bill Into Law - November 8th, 2009 [November 8th, 2009]
- Curing Blood Diseases: How Cord Blood Saves Lives - November 8th, 2009 [November 8th, 2009]
- Cord Blood Registry Gains Momentum in First Quarter; Forecasts Strong Enrollment Growth in 2008 - November 8th, 2009 [November 8th, 2009]
- Study findings from University of Florida, Department of Pediatrics provide new insights into cord blood - November 8th, 2009 [November 8th, 2009]
- Cord Blood Can Be Used To Treat Adult Leukemia - November 8th, 2009 [November 8th, 2009]
- Umbilical cord a lifeline for 2 kids - November 8th, 2009 [November 8th, 2009]
- For Stem Cells, a Role on the Battlefield - November 8th, 2009 [November 8th, 2009]
- Cochlear Repair After Transplant Of Human Cord Blood Cells May Make Hearing Restoration Possible - November 8th, 2009 [November 8th, 2009]
- About Stem Cells - November 8th, 2009 [November 8th, 2009]
- Stem cells: Small wonders - November 8th, 2009 [November 8th, 2009]
- Stem Cell Therapy Lessens Damage Caused By Stroke - November 8th, 2009 [November 8th, 2009]