Melphalan
It works by alkylating and crosslinking DNA, leading to cell death.
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With intelligent comparisons, users can identify the best methodologies and products to enhance the reproducibility and accruacy of their Melphalan research.
Most cited protocols related to «Melphalan»
Trial profile
*Randomisation occurred between May 26, 2010, and April 20, 2016. †Randomisation occurred between Jan 13, 2011, and Aug 11, 2017. ‡Censored for progression-free survival analysis.
Patients who were young and fit to tolerate autologous stem-cell transplantation (transplantation eligible) entered the intensive treatment pathway. Older and less fit patients (transplantation ineligible) entered the non-intensive treatment pathway. Strict age limits were deliberately avoided so that fit, older patients could receive intensive therapy and undergo autologous stem-cell transplantation. However, generally, patients aged 60 years or younger entered the intensive (younger, fitter) pathway; those aged 70 years or older entered the non-intensive (older, less fit) pathway; and those aged 61–69 years were eligible for either intensive or non-intensive therapy. The decision of treatment pathway was made on an individual patient basis, taking into account Eastern Cooperative Oncology Group performance status, clinician judgment, and patient preference.
For the maintenance therapy randomisation, eligible patients were those who completed their assigned induction therapy according to the protocol (a minimum of four cycles of cyclophosphamide, thalidomide, and dexamethasone [CTD]; cyclophosphamide, lenalidomide, and dexamethasone [CRD]; or carfilzomib, cyclophosphamide, lenalidomide, and dexamethasone [KCRD] in the intensive pathway, or a minimum of six cycles of attenuated CTD or attenuated CRD in the non-intensive pathway), and had achieved at least a minimal response and received at least 100 mg/m2 melphalan if assigned to intensive treatment.
The study was approved by the national ethics review board (National Research Ethics Service, London, UK), institutional review boards of the participating centres, and the competent regulatory authority (Medicines and Healthcare Products Regulatory Agency, London, UK), and was undertaken according to the Declaration of Helsinki and the principles of Good Clinical Practice as espoused in the Medicines for Human Use (Clinical Trials) Regulations. All patients provided written informed consent. The study is closed for accrual, but follow-up continues for planned long-term analysis.
The selectivity index (SI), which indicates the cytotoxic selectivity (ie safety) of the crude extract against cancer cells versus normal cells [9 (link)], was calculated from the IC50 of the crude sample in normal cells versus cancer cells.
Most recents protocols related to «Melphalan»
Example 13
NLT 80% of batch volume ethanol was transferred into a manufacturing vessel.
Propylene glycol was added to a vessel containing ethanol. Melphalan was added to the above mixture. Check the pH of the sample and if required adjust the pH to 3.5-5.5 using 0.1N NaOH/0.1N HCL. Final batch volume was made up using ethanol. The obtained solution was filtered and filled in vials followed by capping and sealing. The formulation was tested for stability at 2-8° C. for a period of 1 Month. Stability data is summarized 13A.
Although the formulations, compositions, schemes and methods of the present disclosure have been described with reference to exemplary embodiments thereof, the present disclosure is not limited thereby. Indeed, the exemplary embodiments are implementations of the disclosed methods are provided for illustrative and non-limitative purposes. Changes, modifications, enhancements and/or refinements to the disclosed methods may be made without departing from the spirit or scope of the present disclosure. Accordingly, such changes, modifications, enhancements and/or refinements are encompassed within the scope of the present invention. All publications, patent applications, patents, figures and other references mentioned herein are expressly incorporated by reference in their entirety.
Example 5
EDTA was dissolved in water and added to a manufacturing vessel containing a mixture of PEG and ethanol. Melphalan and povidone were added to the above solution mixture. pH was adjusted to 3.5-5.5 using 0.1N HCl. Volume was made up using mixture of PEG and ethanol. The obtained solution was filtered and filled in vials followed by capping and sealing. The formulation was tested for stability at 25° C./60% RH for a period of 22 days. Stability data is summarized in Table 5A.
Example 4
EDTA was dissolved in water and added to a manufacturing vessel containing a mixture of PEG and ethanol to obtain a clear solution. Melphalan was added to the above solution mixture. pH was adjusted to 3.5-5.5 using 0.1N HCl. Volume was made up using mixture of PEG and ethanol. The obtained solution was filtered and filled in vials followed by capping and sealing. The formulation was tested for stability at 2-8° C. for a period of 5 months. Stability data is summarized in Table 4A.
Example 10
EDTA was dissolved in water and added to a manufacturing vessel containing a mixture of PG and benzyl alcohol. Melphalan was added to the above solution mixture. pH was adjusted between pH 3.5-5.5 using 0.1N HCl/0.1N NaOH. Volume was made up using PG and benzyl alcohol. The obtained solution was filtered and filled in vials followed by capping and sealing. The formulation was tested for stability at 2-8° C. for a period of 22 days. Stability data is summarized in Table 10A.
Example 7
EDTA and povidone was dissolved in water and added to a manufacturing vessel containing a mixture of PG and ethanol. Melphalan and povidone were added to the above solution mixture. pH was adjusted to 7.5-9.0 using 0.1 N NaOH. Volume was made up using PG and ethanol. The obtained solution was filtered and filled in vials followed by capping and sealing. The formulation was tested for stability at 25° C./60% RH for a period of 22 days. Stability data is summarized in Table 7A.
Table 7A
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More about "Melphalan"
This alkylating agent works by damaging DNA, leading to cell death.
PubCompare.ai, an AI-powered platform, helps researchers optimize Melphalan studies by surfacing the most relevant protocols from scientific literature, preprints, and patents.
By enabling intelligent comparisons, the tool allows users to identify the best methodologies and products to enhance the reproducibility and accuracy of their Melphalan research.
Melphalan is often used in combination with other chemotherapeutic drugs, such as Bortezomib and Doxorubicin, to treat multiple myeloma.
Additionally, Dexamethasone, a corticosteroid, is frequently administered alongside Melphalan to manage side effects and improve treatment outcomes.
When conducting Melphalan studies, researchers may utilize various cell culture techniques, including the use of RPMI8226 cell lines and supplementing the growth medium with Fetal Bovine Serum (FBS) and Penicillin/Streptomycin antibiotics.
The CliniMACS CD34 Reagent System may also be employed to isolate and purify specific cell populations for Melphalan-related research.
By leveraging the insights provided by PubCompare.ai, researchers can optimize their Melphalan studies, leading to more reproducible and accurate results, ultimately advancing the understanding and treatment of multiple myeloma, ovarian cancer, and other malignancies.