Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma

Официальное название

Prospective, Multicenter, Open and Non-interference Observational Clinical Study of Daratumumab, Pomalidomide and Dexamethasone (Dara-PD) in the Treatment of Patients With First Relapse of Multiple Myeloma

Обзор

At present, there is no prospective study on the treatment of first-relapsed multiple myeloma with daratumumab plus pomalidomide and dexamethasone (Dara-Pd). A prospective, multicenter, open, non-interventional, observational clinical study to evaluate the efficacy and safety of Dara-Pd in patients with first relapse multiple myeloma.

Подробное описание

To evaluate the impact of daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma. Among them, the second progression free survival time (PFS2) is defined as the time from enrollment to disease progression or death.

Первичные конечные точки

• the second progression free survival time (PFS2) [Срок оценки: through study completion, up to 2 years]

Вторичные конечные точки (7)

• Objective Response Rate (ORR) [Срок оценки: through study completion, up to 2 years]
• Deep response rate (≥ VGPR) [Срок оценки: through study completion, up to 2 years]
• MRD negative [Срок оценки: through study completion, up to 2 years]
• continuous MRD negative rate [Срок оценки: through study completion, up to 2 years]
• Overall survival (OS) [Срок оценки: through study completion, up to 2 years]
• Evaluation of duration of remission (DOR) [Срок оценки: through study completion, up to 2 years]
• Treatment related adverse event(AE) [Срок оценки: From enrollment through follow-up (up to 24 months).]

Критерии участия

Критерии включения

Subjects will be enrolled in this study only if they met all of the following inclusion criteria.

• Age 18 years or older, regardless of gender.
• Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease
• First relapse of multiple myeloma;
• Receiving first-line anti-multiple myeloma therapy;
• The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD);
• Subject must have achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen;
• Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
• Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.

Критерии исключения

• Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma.
• Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course；
• Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy；
• Subject has received daratumumab or pomalidomide previously；
• Subject has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions is malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).；
• Subjects with uncontrollable psychiatric disorders;
• Subject is known or suspected of not being able to comply with the study protocol.Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Hospital of Jilin University — Changchun

Публикации

• Majithia N, Rajkumar SV, Lacy MQ, Buadi FK, Dispenzieri A, Gertz MA, Hayman SR, Dingli D, Kapoor P, Hwa L, Lust JA, Russell SJ, Go RS, Kyle RA, Kumar SK. Early relapse following initial therapy for multiple myeloma predicts poor outcomes in the era of novel agents. Leukemia. 2016 Nov;30(11):2208-2213. doi: 10.1038/leu.2016.147. Epub 2016 May 23. PMID 27211270
• Minnie SA, Hill GR. Immunotherapy of multiple myeloma. J Clin Invest. 2020 Apr 1;130(4):1565-1575. doi: 10.1172/JCI129205. PMID 32149732
• An G, Li Z, Tai YT, Acharya C, Li Q, Qin X, Yi S, Xu Y, Feng X, Li C, Zhao J, Shi L, Zang M, Deng S, Sui W, Hao M, Zou D, Zhao Y, Qi J, Cheng T, Ru K, Wang J, Anderson KC, Qiu L. The impact of clone size on the prognostic value of chromosome aberrations by fluorescence in situ hybridization in multiple myeloma. Clin Cancer Res. 2015 May 1;21(9):2148-56. doi: 10.1158/1078-0432.CCR-14-2576. Epub 201 PMID 25652456
• An G, Acharya C, Feng X, Wen K, Zhong M, Zhang L, Munshi NC, Qiu L, Tai YT, Anderson KC. Osteoclasts promote immune suppressive microenvironment in multiple myeloma: therapeutic implication. Blood. 2016 Sep 22;128(12):1590-603. doi: 10.1182/blood-2016-03-707547. Epub 2016 Jul 14. PMID 27418644
• Riccardi A, Mora O, Tinelli C, Porta C, Danova M, Brugnatelli S, Grasso D, Tolca B, Spanedda R, De Paoli A, Barbarano L, Cavanna L, Giordano M, Delfini C, Nicoletti G, Bergonzi C, Rinaldi E, Piccinini L, Ascari E. Response to first-line chemotherapy and long-term survival in patients with multiple myeloma: results of the MM87 prospective randomised protocol. Eur J Cancer. 2003 Jan;39(1):31-7. doi: PMID 12504655
• Durie BG, Jacobson J, Barlogie B, Crowley J. Magnitude of response with myeloma frontline therapy does not predict outcome: importance of time to progression in southwest oncology group chemotherapy trials. J Clin Oncol. 2004 May 15;22(10):1857-63. doi: 10.1200/JCO.2004.05.111. Epub 2004 Apr 26. PMID 15111617
• Chinese Hematology Association; Chinese Society of Hematology. [Guidelines for the diagnosis and management of multiple myeloma in China (2022 revision)]. Zhonghua Nei Ke Za Zhi. 2022 May 1;61(5):480-487. doi: 10.3760/cma.j.cn112138-20220309-00165. Chinese. PMID 35488597
• Overdijk MB, Verploegen S, Bogels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, Groen RW, Breij E, Martens AC, Bleeker WK, Parren PW. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7(2):311-21. doi: 10.1080/19420862.2015.1007813. PMID 25760767

Идентификаторы

NCT: NCT06252792 · First relapse multiple myeloma

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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