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    DRUG:

    captisol-enabled melphalan

    i
    Other names: CE melphalan, LGD-353
    Associations

    News

    Trials
    Company:
    Generic mfg.
    Drug class:
    DNA synthesis inhibitor, Alkylating agent
    Related drugs:
    Associations

    News

    Trials
    2ms
    Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant. (clinicaltrials.gov)
    P1, N=46, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    Neulasta (pegfilgrastim) • captisol-enabled melphalan
    4ms
    Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=40, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open • Pre-transplantation • Post-transplantation
    |
    lenalidomide • Elrexfio (elranatamab-bcmm) • busulfan • captisol-enabled melphalan • plerixafor
    4ms
    NCI-2018-00906: Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation (clinicaltrials.gov)
    P1/2, N=62, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jul 2024 | Trial primary completion date: Dec 2024 --> Jul 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    Neupogen (filgrastim) • captisol-enabled melphalan
    5ms
    Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
    P2, N=40, Completed, Case Comprehensive Cancer Center | Trial completion date: Jun 2025 --> Jun 2024 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    fludarabine IV • thiotepa • captisol-enabled melphalan
    6ms
    NCI-2017-01069: Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Feb 2024 --> May 2027 | Trial primary completion date: Feb 2024 --> Aug 2023
    Trial completion date • Trial primary completion date • Post-transplantation
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    cyclophosphamide • sirolimus • fludarabine IV • captisol-enabled melphalan
    6ms
    Evaluate Safety and Efficacy of High-dose Melphalan HCL for Injection in MM Patients With Auto-HSC Transplantation (clinicaltrials.gov)
    P4, N=67, Completed, CASI Pharmaceuticals (China) Co., Ltd.
    New P4 trial
    |
    captisol-enabled melphalan
    8ms
    Melphalan on Disease Burden Measured by Next Generation Sequencing Before AHCT (Autologous Hematopoietic Cell Transplant) for Multiple Myeloma (clinicaltrials.gov)
    P1, N=0, Withdrawn, Koen van Besien | N=20 --> 0 | Trial completion date: Sep 2023 --> Mar 2024 | Recruiting --> Withdrawn | Trial primary completion date: Jun 2023 --> Dec 2023
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    captisol-enabled melphalan
    10ms
    Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial • Pre-transplantation • Post-transplantation
    |
    lenalidomide • Elrexfio (elranatamab-bcmm) • busulfan • captisol-enabled melphalan • plerixafor
    11ms
    High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant (clinicaltrials.gov)
    P2, N=38, Completed, City of Hope Medical Center | Active, not recruiting --> Completed
    Trial completion • Post-transplantation
    |
    cyclophosphamide • fludarabine IV • busulfan • captisol-enabled melphalan
    11ms
    Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation (clinicaltrials.gov)
    P2, N=43, Recruiting, Medical College of Wisconsin | Trial primary completion date: Sep 2024 --> Nov 2025
    Trial primary completion date
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    fludarabine IV • captisol-enabled melphalan
    12ms
    Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Case Comprehensive Cancer Center | Trial completion date: Dec 2025 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    fludarabine IV • thiotepa • captisol-enabled melphalan
    1year
    Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation (clinicaltrials.gov)
    P1/2, N=62, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    Neupogen (filgrastim) • captisol-enabled melphalan
    1year
    Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant. (clinicaltrials.gov)
    P1, N=46, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    Neulasta (pegfilgrastim) • captisol-enabled melphalan
    1year
    Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
    P3, N=724, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • carboplatin • Lorbrena (lorlatinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • thiotepa • Qarziba (dinutuximab beta) • busulfan • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • dexrazoxane
    over1year
    Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation (clinicaltrials.gov)
    P2, N=43, Recruiting, Medical College of Wisconsin | Trial completion date: Jul 2024 --> Sep 2025 | Trial primary completion date: Jul 2023 --> Sep 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    fludarabine IV • captisol-enabled melphalan
    over1year
    High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant (clinicaltrials.gov)
    P2, N=38, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2023 --> Dec 2023
    Trial completion date • Post-transplantation
    |
    cyclophosphamide • fludarabine IV • busulfan • captisol-enabled melphalan
    over1year
    Efficacy of a prolonged stability melphalan formulation for intra-arterial treatment of retinoblastoma. (PubMed, J Neurointerv Surg)
    Evomela has non-inferior safety and efficacy relative to SFM when used for the treatment of retinoblastoma by selective ophthalmic artery infusion.
    Journal
    |
    melphalan • captisol-enabled melphalan
    over1year
    Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Case Comprehensive Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Dec 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    fludarabine IV • thiotepa • captisol-enabled melphalan
    over1year
    Intra-arterial Chemotherapy for Retinoblastoma (clinicaltrials.gov)
    P1, N=5, Active, not recruiting, Washington University School of Medicine | Trial completion date: Aug 2025 --> Jan 2025 | Trial primary completion date: Aug 2023 --> Jan 2023
    Trial completion date • Trial primary completion date
    |
    captisol-enabled melphalan
    over1year
    NCI-2017-01069: Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Aug 2025 --> Feb 2024 | Trial primary completion date: Aug 2025 --> Feb 2024
    Trial completion date • Trial primary completion date • Post-transplantation
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    cyclophosphamide • sirolimus • fludarabine IV • captisol-enabled melphalan
    over1year
    NCI-2017-01069: Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, Roswell Park Cancer Institute | Recruiting --> Active, not recruiting
    Enrollment closed • Post-transplantation
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    cyclophosphamide • sirolimus • fludarabine IV • captisol-enabled melphalan
    almost2years
    Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
    P2, N=39, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Jan 2024 --> Jun 2025 | Trial primary completion date: Jan 2023 --> Jun 2023
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    fludarabine IV • thiotepa • captisol-enabled melphalan
    almost2years
    Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant. (clinicaltrials.gov)
    P1, N=46, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Sep 2022 --> Sep 2023
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    Neulasta (pegfilgrastim) • captisol-enabled melphalan
    2years
    A Phase IV, Multicenter, Open-Label, Safety, and Efficacy Study of High-Dose, Propylene Glycol-Free Melphalan Hydrochloride for Injection (EVOMELA) As a Myeloablative Conditioning Regimen in Chinese Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation (ASH 2022)
    To our knowledge, this is the largest prospective study to date to demonstrate the safety and efficacy of EVOMELA as a high-dose conditioning regimen for ASCT in Chinese MM patients. EVOMELA was shown to be safe and well-tolerated that most of the AEs were transient or manageable with no unexpected toxicities. High-dose therapy induced myeloablation in all patients and allowed for successful timely engraftments of both neutrophils and platelets.
    Clinical • P4 data
    |
    CD34 (CD34 molecule)
    |
    captisol-enabled melphalan
    2years
    Melphalan on Disease Burden Measured by Next Generation Sequencing Before AHCT (Autologous Hematopoietic Cell Transplant) for Multiple Myeloma (clinicaltrials.gov)
    P1, N=20, Recruiting, Ehsan Malek | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD34 (CD34 molecule)
    |
    captisol-enabled melphalan
    over2years
    Melphalan on Disease Burden Measured by Next Generation Sequencing Before AHCT (Autologous Hematopoietic Cell Transplant) for Multiple Myeloma (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Ehsan Malek | Initiation date: Mar 2022 --> Sep 2022
    Trial initiation date
    |
    CD34 (CD34 molecule)
    |
    captisol-enabled melphalan
    over2years
    NCI-2017-01069: Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
    P1/2, N=33, Recruiting, Roswell Park Cancer Institute | Phase classification: P2 --> P1/2 | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2022 --> Aug 2025
    Phase classification • Trial completion date • Trial primary completion date
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    sirolimus • fludarabine IV • captisol-enabled melphalan
    almost3years
    Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
    P2, N=39, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Jan 2022 --> Jan 2024 | Trial primary completion date: Jan 2022 --> Jan 2023
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    fludarabine IV • thiotepa • Kepivance (palifermin) • captisol-enabled melphalan
    almost3years
    Melphalan on Disease Burden Measured by Next Generation Sequencing Before AHCT (Autologous Hematopoietic Cell Transplant) for Multiple Myeloma (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Ehsan Malek | Trial completion date: Sep 2022 --> Sep 2023 | Initiation date: Oct 2021 --> Mar 2022 | Trial primary completion date: Jun 2022 --> Jun 2023
    Clinical • Trial completion date • Trial initiation date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    captisol-enabled melphalan
    almost3years
    Next-Generation Sequencing to Assess the Impact of Low Dose Melphalan on Residual Disease before High-Dose Melphalan and Stem Cell Transplant in Multiple Myeloma (ASH 2021)
    We will administer propylene glycol-free melphalan formulation (EVOMELA) due to greater stability upon reconstitution than AlKERAN formulation in order to diminish the variability in the effective administered dose. We will assume 20% failure rate for VJD clonal sequencing and calibration efficacy by clonoSEQ. Therefore, by enrolling 20 patients, we expect that at least 16 patients will have MRD assessable by NGS method.
    Next-generation sequencing
    |
    clonoSEQ
    |
    melphalan • captisol-enabled melphalan
    over3years
    Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
    P2, N=30, Recruiting, Roswell Park Cancer Institute | Trial completion date: Jul 2022 --> Aug 2023 | Trial primary completion date: Jul 2021 --> Aug 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    sirolimus • fludarabine IV • captisol-enabled melphalan • cyclophosphamide intravenous
    over3years
    Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant. (clinicaltrials.gov)
    P1, N=46, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    Neulasta (pegfilgrastim) • captisol-enabled melphalan
    over3years
    Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation (clinicaltrials.gov)
    P2, N=43, Recruiting, Medical College of Wisconsin | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2021 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    fludarabine IV • captisol-enabled melphalan
    over3years
    Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
    P2, N=39, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Jul 2022 --> Jan 2022 | Trial primary completion date: Apr 2021 --> Jan 2022
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    fludarabine IV • thiotepa • Kepivance (palifermin) • captisol-enabled melphalan
    over3years
    Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma (clinicaltrials.gov)
    P3, N=813, Recruiting, Children's Oncology Group | Active, not recruiting --> Recruiting
    Clinical • Enrollment open
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • Xalkori (crizotinib) • carboplatin • doxorubicin hydrochloride • etoposide IV • vincristine • topotecan • thiotepa • busulfan • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • cyclophosphamide intravenous • dexrazoxane
    almost4years
    Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma (clinicaltrials.gov)
    P3, N=813, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
    |
    MYCN amplification
    |
    cisplatin • Xalkori (crizotinib) • carboplatin • doxorubicin hydrochloride • etoposide IV • vincristine • topotecan • thiotepa • busulfan • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • cyclophosphamide intravenous • dexrazoxane
    almost4years
    Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
    P2, N=39, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Dec 2022 --> Jul 2022 | Trial primary completion date: Dec 2020 --> Apr 2021
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    fludarabine IV • thiotepa • Kepivance (palifermin) • captisol-enabled melphalan
    over4years
    Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
    P2, N=39, Recruiting, Case Comprehensive Cancer Center | Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2020 --> Dec 2020
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    fludarabine IV • thiotepa • Kepivance (palifermin) • captisol-enabled melphalan