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Myeloma, Plasma-Cell clinical trials

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NCT ID: NCT04065789 Completed - Plasma Cell Myeloma Clinical Trials

Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM Patients

KyDaR
Start date: May 2, 2018
Phase: Phase 2
Study type: Interventional

Patients with newly diagnosed multiple myeloma (NDMM) who failed to achieve at least a minimal response (MR) after 2 cycles or a partial response (PR), after 4 cycles of a bortezomib-containing therapy, or progress on therapy during first 4 cycles (response defined by international Myeloma Working Group [IMWG] criteria), will be treated with a quadruple regimen comprised of: Daratumumab 16 mg/Kg weekly during cycles 1-2, q14 days during cycles 3-6, thereafter monthly (1st dose cycle 1 may be split over 2 days); Once-weekly intravenous (IV) administration of Carfilzomib on days 1, 8, 15, of cycle numbers 1-9 and Days 1 and 15 only of cycle numbers 10-18, at a dose of 20 mg/m2 on day 1 of cycle 1; at dose of 56 mg/m2 on all subsequent once weekly dosing days, alongside concomitant treatment with twice-weekly IV or oral dexamethasone 20mg administered on Days 1-2, 8-9, 15-16, and 22-23 of a 28-day cycle, for cycles 1-2 followed by weekly 20 mg dexamethasone on subsequent cycles; and oral Lenalidomide 25 mg, administered on days 1-21 of a 28-day cycle. On treatment days that require both Carfilzomib and Daratumumab infusions, Carfilzomib will be administrated prior to Daratumumab administration. All patients will undergo frailty assessment based on IMWG recommendations, and will be classified as fit, intermediate-fit and frail. Frail patients will receive Lenalidomide dose adjustment to 15 mg (throughout the study, from cycle 1 and on), and dexamethasone at 10 mg x 2/week cycles 1-2 followed by 10 mg/week for subsequent cycles. The quadruple regimen will be administered for 18 cycles, followed by long-term follow-up in which patients will receive standard of care treatment with Lenalidomide/dexamethasone (Rd) treatment, unless disease progression, the physician decides otherwise, the patient suffers from unacceptable toxicity, withdraws consent, or dies (whichever occurs first).

NCT ID: NCT03958656 Completed - Myeloma-Multiple Clinical Trials

T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma

Start date: June 13, 2019
Phase: Phase 1
Study type: Interventional

Background: Multiple myeloma is a blood cancer that is usually incurable. T cells are part of the immune system. Researchers think changing a person's T cells to recognize their cancer could help the person's body kill tumor cells. This is a new approach that uses a patient's own cells to target multiple myeloma. Objective: To see if giving anti-Signaling lymphocytic activation molecule F7 (SLAM7) chimeric antigen receptor (CAR) T cells with a stop switch to people with multiple myeloma is safe and to see if adding a gene to stop T-cell activity can limit toxicity of this therapy. Eligibility: People ages 18-73 with multiple myeloma for which prior standard treatment has not worked Design: Participants will be screened with: - Medical history - Physical exam - Blood, urine, and heart tests - Bone marrow samples: A needle inserted into the participant's bone will remove marrow. - Imaging scans: Participants will lie in a machine that takes pictures of the body. Participants will have apheresis. They will receive a catheter or central line: A plastic tube will be inserted into a chest or arm vein. Blood will be removed and the T cells separated. The rest of the blood will be returned to the participant. The T cells will be manipulated in the lab. Participants will get chemotherapy through the central line for 3 days. Participants will receive the manipulated T cells through the central line. They will stay in the hospital at least 9 days. Participants will have follow-up visits 2 weeks then 1, 2, 3, 4, 6, 9, and 12 months after the infusion. They will then have visits every 6 months for 3 years. Then they will be contacted once per year for 15 years. All visits will include blood tests, and 3 visits will include bone marrow biopsies....

NCT ID: NCT02215967 Completed - Myeloma-Multiple Clinical Trials

Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma

Start date: August 12, 2014
Phase: Phase 1
Study type: Interventional

Background: - T cells are white blood cells that fight several cancers. One cancer therapy involves removing a persons' T cells, changing them in a lab, and then returning them to the person. Researchers want to see if this helps people with multiple myeloma. Objective: - To test the safety of giving anti-B-Cell Maturation Antigen T cells to people with multiple myeloma. Eligibility: - Adults ages 18-70 with multiple myeloma that has not responded to standard therapies. Design: - Participants may be screened with: - Medical history - Physical exam - Blood and urine tests - Heart tests - Bone marrow sample - Multiple scans and X-rays - Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm. - The cells will be changed in a laboratory. - Participants will get 2 chemotherapy drugs over 3 days. - Two days later, participants will check into the hospital. They will get an intravenous (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion. - After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor. - Participants will visit the clinic 1, 2, 3, 4, 6, and 12 months after the infusion, then every 6 months. A bone marrow sample will be taken at the 2-month visit. - Participants blood will be collected for several years. Participants will have an annual physical at National Institutes of Health (NIH) for 5 years after the infusion. Then for 10 years they will answer health questionnaires.

NCT ID: NCT00600353 Completed - Lymphoma, Malignant Clinical Trials

Multi-day Doses in Prevention of Nausea and Emesis

Start date: October 2007
Phase: Phase 2
Study type: Interventional

To assess emetic responses to multi-day doses of Palonosetron and Aprepitant and low dose dexamethasone +/- Prochlorperazine among patients with multiple myeloma and lymphoma undergoing autologous HSCT utilizing the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).

NCT ID: NCT00421525 Completed - Multiple Myeloma Clinical Trials

Phase I/II Study of hLL1 in Multiple Myeloma

Start date: January 2007
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, open-label, multi-center study conducted in patients with recurrent or refractory multiple myeloma who have failed at least two prior standard systemic treatments.

NCT ID: NCT00146055 Completed - Clinical trials for Myelodysplastic Syndromes

Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood

Start date: March 2000
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether a less-intensive preparative therapy followed by an allogeneic peripheral stem cell transplantation will provide an effective treatment for your disease and whether it will be associated with fewer side effects.