Daratumumab plus lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma: Analysis of vascular thrombotic events in the GRIFFIN study.

Patients with multiple myeloma are at increased risk of vascular thromboembolic events (VTEs). This post hoc analysis evaluated VTEs in the randomised phase 2 GRIFFIN study (ClinicalTrials.gov Identifier: NCT02874742) that investigated lenalidomide/bortezomib/dexamethasone (RVd) ± daratumumab (D). Patients with newly diagnosed multiple myeloma who were eligible for autologous stem cell transplantation (ASCT) received D-RVd/RVd induction, high-dose therapy and ASCT, D-RVd/RVd consolidation and up to 2 years of lenalidomide maintenance therapy ± D. VTE prophylaxis was recommended (at least aspirin, ≥162 mg daily) in accordance with International Myeloma Working Group guidelines. In the safety population (D-RVd, n = 99; RVd, n = 102), VTEs occurred in 10.1% of D-RVd patients and 15.7% of RVd patients; grade 2-4 VTEs occurred in 9.1% and 14.7%, respectively. Median time to the first onset of VTE was longer for D-RVd versus RVd patients (305 days vs 119 days). Anti-thrombosis prophylaxis use was similar between arms (D-RVd, 84.8% vs RVd, 83.3%); among patients with VTEs, prophylaxis use at time of first VTE onset was 60.0% for D-RVd and 68.8% for RVd. In summary, the addition of daratumumab to RVd did not increase the incidence of VTEs, but the cumulative VTE incidence was relatively high in this cohort and anti-thrombotic prophylaxis use was suboptimal.

A plain language summary of daratumumab plus lenalidomide/bortezomib/dexamethasone in transplant-eligible Black patients with newly diagnosed multiple myeloma in the GRIFFIN study.

WHAT IS THIS SUMMARY ABOUT?: This is a summary of a publication about Black participants of the GRIFFIN clinical study that was published in Blood Cancer Journal in April 2022. The GRIFFIN clinical study looked at the treatment combination of daratumumab plus a standard therapy for multiple myeloma (called RVd therapy, which stands for lenalidomide, bortezomib, and dexamethasone) in adult patients who had not been treated before for multiple myeloma and so were considered to have newly diagnosed multiply myeloma. Multiple myeloma is a blood cancer of plasma cells. Based on the participants' age, medical history, and indicators of good general health, the participants in the GRIFFIN study were also eligible to receive autologous stem cell transplant as part of their therapy. This summary describes results for the Black participants of the GRIFFIN clinical study who received daratumumab plus RVd therapy (called D-RVd) to see if D-RVd therapy is better than RVd therapy at reducing the amount of multiple myeloma cancer cells in a patient's body. WHY DID THE RESEARCHERS EVALUATE THE RESULTS FOR BLACK PATIENTS IN THE GRIFFIN STUDY?: Due to racial disparities leading to historically low representation of minority groups in clinical studies, optimal treatments are not defined for Black patients with newly diagnosed multiple myeloma. Since previously published results from the overall population in the GRIFFIN study indicated that D-RVd therapy was better than RVd therapy, the researchers wanted to determine if this was also the case among Black participants. WHAT WERE THE RESULTS?: Out of 207 participants in the GRIFFIN study, 15% (32 participants) were Black and 78% (161 participants) were White. In both Black and White participants, D-RVd therapy reduced the amount of myeloma cancer cells more than RVd therapy. Additionally, D-RVd and RVd therapy had similar safety results for Black and White participants. WHAT DO THE RESULTS MEAN?: This analysis of GRIFFIN by race shows that Black people benefit from the daratumumab-containing D-RVd therapy as much as White people. Additionally, D-RVd therapy had similar safety results to RVd therapy for both Black and White people. Clinical Trial Registration: NCT02874742 (ClinicalTrials.gov).

Comparison of a universal (but complex) model for avian egg shape with a simpler model.

Recently, a universal equation by Narushin, Romanov, and Griffin (hereafter, the NRGE) was proposed to describe the shape of avian eggs. While NRGE can simulate the shape of spherical, ellipsoidal, ovoidal, and pyriform eggs, its predictions were not tested against actual data. Here, we tested the validity of the NRGE by fitting actual data of egg shapes and compared this with the predictions of our simpler model for egg shape (hereafter, the SGE). The eggs of nine bird species were sampled for this purpose. NRGE was found to fit the empirical data of egg shape well, but it did not define the egg length axis (i.e., the rotational symmetric axis), which significantly affected the prediction accuracy. The egg length axis under the NRGE is defined as the maximum distance between two points on the scanned perimeter of the egg's shape. In contrast, the SGE fitted the empirical data better, and had a smaller root-mean-square error than the NRGE for each of the nine eggs. Based on its mathematical simplicity and goodness-of-fit, the SGE appears to be a reliable and useful model for describing egg shape.

Evaluation of Alternative Power Sources for Operating CDC Mosquito Surveillance Traps.

Several portable, rechargeable lithium-ion (Li-Ion) cell phone power banks were compared with standard 6-V gel lead-acid batteries as alternative power sources for operating mosquito surveillance equipment. In laboratory trials, ToughTested® (TT)16000 and 24000, Goal Zero Venture™ 70, and Griffin Survivor® units either met or exceeded that of sealed 6-V batteries when operating the Centers for Disease Control and Prevention (CDC) suction light traps (with incandescent light on) for an average of 24 h. No significant difference was found when continually operating traps powered by either the TT16000 or Goal Zero Venture 70 units compared with 6-V batteries (at approximately 57 h). The TT24000 unit was the only Li-Ion power bank that exceeded this threshold at an average of approximately 73 h. In field studies, there was no significant difference in species diversity or abundance of mosquitoes among the above 4 power sources when operating CDC light traps for 24 h compared with 6-V batteries. Our results indicate that portable Li-Ion cell phone power banks ≥10,050 mAh may be suitable replacements for 6-V gel lead-acid batteries when operating these light traps, especially if weight and size constraints influence the extent of mosquito surveillance during deployments.

Intertrochanteric Hip Fractures And Vitamin D Deficiency; A Significant Association.

BACKGROUND: Intertrochanteric fractures are a common cause of disability, morbidity and mortality in aged population across the globe. The same population is also vulnerable to ill effects of vitamin D deficiency and presence of multiple comorbidities. Very few studies have been done in our part of the world to find the association of vitamin D deficiency with type of intertrochanteric fractures. METHODS: This cross-sectional study was conducted during July 2019 to June 2020 at tertiary care hospital in the megacity of Lahore, Pakistan. Demographic variables were recorded and anteroposterior and lateral views of plain radiographs were used to classify the fractures. History of chronic illness was taken and confirmed with available prescription. Vitamin D level was measured using standard laboratory techniques. Data was entered into IBM SPSS Statistics (version 25) software and analysed. RESULTS: Mean age for males was 65 years and for females 71 years. Boyd and Griffin type II fracture was most common injury (62%). 67% of our study population was suffering from some degree of vitamin D deficiency. Results have shown the significant association of vitamin D deficiency and severity of intertrochanteric fractures (p <0.05). There was no significant difference of degree of vitamin D deficiency and injury pattern among both genders. CONCLUSIONS: There is a strong association between degree of vitamin D deficiency and type of intertrochanteric fractures. Our study also highlighted the importance of mechanism of injury, age and presence of diabetes in association with these fractures.

Growth comparison of Acanthamoeba genotypes T3 and T4 in several culture media.

Acanthamoeba causes severe diseases such as Granulomatous Amebic Encephalitis (GAE) and Acanthamoeba keratitis (AK). Improving the culture media classically used for this amoeba could help to identify it quickly and facilitate its study as a biological model. The purpose of this study was to compare the growth of two Acanthamoeba genotypes (T3 and T4) in several culture media. Acanthamoeba griffini (T3 genotype) and Acanthamoeba castellanii (T4 genotype) were cultured in PYG, TSY, TYI-S-33, RPMI, and RPMI-FBS medium. The number of amoebas grown in different culture media was counted and compared to each other for 14 days. Findings in this research revealed the highest growth in RPMI-FBS medium. For this reason, we can recommend this culture medium to promote the growth of Acanthamoeba in its biological studies.

Forced cesareans: the most unkindest cut of all.

KIE: The author reviews and criticizes two recent cases in which the Georgia Supreme Court and a juvenile court in Denver, Colorado, ordered women who were refusing surgical interventions during labor to undergo them. He contends that the judges had to decide too hastily for adequate analysis of the legal precedents, and argues that medical, ethical, legal, and practical considerations support the right of a pregnant woman to refuse surgery recommended for the sake of her fetus.^ieng

Jefferson v. Griffin Spalding County Hospital Authority: court-ordered surgery to protect the life of an unborn child.

In Jefferson v. Griffin Spalding County Hospital Authority, the Supreme Court of Georgia affirmed a lower court order requiring a pregnant woman to submit to a cesarian section and other medical procedures necessary to save her unborn child's life. The court found that the state's interest in protecting the viable fetus outweighed the pregnant mother's right to religious practice, right to refuse medical treatment, and parental autonomy. Jefferson appears to stand for the proposition that fetuses have rights that attach at viability and that mothers have a corresponding duty to ensure live births. The decision foreshadows substantial conflict between fetal and maternal rights.

Legislating to preserve women's autonomy during pregnancy.

Women are often excluded from the process of medical decision making during pregnancy, even though medical decisions that are made by health care professionals affect them personally and affect the future well-being of the unborn. Women in general and pregnant women in particular, will feel the impact of new genetic tests and technologies, designed to predict and even treat certain genetic problems during pregnancy, through prenatal diagnosis, foetal surgery and foetal gene therapy. This may be the first of several implications that new genetics technologies will hold for women's autonomy during pregnancy. Does genetic testing of a foetus empower women or pose an unanticipated threat to autonomy? To address these issues, there is a need to articulate a feminist perspective on genetic testing and possibly to legislate protection of women's rights during prenatal care. This article raises, but does not answer, several important issues regarding the implications of new developments in genetic testing that will affect pregnant women's autonomy in medical decision making. The article concludes that, although there are United States constitutional protections for the right to abortion and in turn, therapeutic abortion, an unfavourable chain of precedents regarding women's autonomy during pregnancy makes it imperative that there be strong legislation providing assurances that information will be given to pregnant women about the genetic testing process; that women will be made aware of their right to refuse treatment; that the law will require health care professionals to give adequate information to pregnant women regarding possible treatment outcomes in order to make an informed choice; and that there will be adequate protection for the right to confidentiality of information regarding prenatal prognosis, in order to safeguard autonomous decision making during pregnancy.

Jefferson v. Griffin Spalding County Hospital Authority.

KIE: The Georgia Supreme Court affirmed an order of the Butts County Superior Court requiring a pregnant woman who was carrying a viable fetus to submit to a cesarean section delivery and granting temporary custody of the fetus to the Department of Human Resources. The examining physician had discovered that the mother had a complete placenta previa, with the placenta being located between the fetus and the birth canal, making it a 99% certainty that the fetus could not survive natural childbirth and a 50% chance that the mother would not survive. The mother had declined cesarean section or accompanying blood transfusions for religious reasons.^ieng

Resolving the clinical and ethical dilemma involved in fetal-maternal conflicts.

A serious ethical dilemma occurs when a pregnant woman refuses a medically indicated intervention. Should respect for her autonomy preclude any approach other than to accept her decision? Should the caregivers have recourse to "gentle persuasion"? Is there ever a justification for invoking the power of court-ordered intervention? The societal views on this subject are first developed from an ethical perspective. The pertinent court cases that reflect on this topic are reviewed. The process of developing guidelines within our institution is related. Finally, the guidelines that were eventually developed are offered.

Contemporary transatlantic developments concerning compelled medical treatment of pregnant women.

This paper had identified a contemporary ethicolegal dilemma concerning the circumstances, if any, in which a pregnant woman's refusal of medical treatment may be judicially overridden either in her interests or those of the unborn child. On the one hand, the obstetrician will be concerned about the interests of both his patients in potentially life-threatening situations when they can be protected by what might be regarded as relatively straightforward procedures and where to fail to take those steps might expose the practitioner (at least outside New Zealand where its accident compensation legislation has impact in this regard) to allegations of negligence. On the other hand, the imposition of treatment in these circumstances will necessarily interfere with the woman's rights of autonomy and self-determination. In such cases also, the conduct of medical procedures in the face of an express prohibition by the woman may give rise to liability for battery. (In New Zealand, such a potential liability would not, in the writer's view, be affected by the prohibition on proceedings for damages for medical misadventure as contained in the Accident Rehabilitation and Compensation Insurance Act 1992.) At the heart of an analysis of this issue is the status of the fetus as it is the fact of the woman patient's pregnancy which distinguishes the cases discussed in this paper from others in which the Courts have had to deal with refusals of treatment by those competent to do so. In regard to this aspect, the approach of the Courts in various jurisdictions has arguably been confused and contradictory.(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: This article reviews and analyzes US and UK court decisions concerning the circumstances (if any) in which medical treatment of a pregnant woman is lawful in the absence or refusal of consent. This issue is of practical importance to physicians and raises ethicolegal issues about the relative and competing rights of a pregnant woman and the fetus. A brief overview is provided of the general principles of consent and relevance, and situations in which the "doctrine of necessity" (which allows treatment to be given without consent) may and may not be invoked are outlined. The general status of the fetus as contained in relevant civil law and the right of the fetus to sue as a result of injury inflicted in utero are then reviewed in light of key decisions made in England and Australia. Court decisions on whether a fetus can be "warded" and placed under an order of guardianship are also reviewed. Three US cases in which the courts were asked to override a pregnant woman's refusal to consent to treatment are then detailed. In one case, the pregnant woman was ordered to undergo a sonogram and to submit to a Cesarean section if the placenta was still malpositioned. In a second case, a Cesarean was ordered for a woman near death from cancer. This action was overturned after the fact (and the woman's and baby's deaths) by an appeals court. In the third case, the court refused to order a Cesarean section when doctors predicted the fetus would not otherwise survive. In Britain, the court allowed a blood transfusion to a lapsed Jehovah's Witness who was comatose and had miscarried as the result of a traffic accident. The second case, in which the ruling has been criticized, permitted a Cesarean in a woman whose fetus was malpositioned. These rulings have centered on the status of the fetus and have, therefore, suffered from confusion. They have also suffered from hasty decisions made in perceived emergency situations. In the US, maternal rights are outweighing fetal rights. It has been concluded that courts should not compel pregnant women to submit to medical treatment and any judicial authority in these matters should arise from legislation.