Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunoglobulins, Intravenous

Isatuximab will be given intravenously (IV) at the dose of 10 mg/kg on Days 1, 8, 15, 22 (cycle 1), 36, 50 (cycle 2), 64, 78 (cycle 3) and monthly thereafter (cycles 4-36).

CellProtect will be given IV infusion at the dose of 3x10\^7 cells/kg day 29 , 43 and 3-10x10\^7 on day 57.

Each cycle will be 28 days, after completion of third cycles, patients will continue with Isatuximab alone until disease progression, unacceptable AE, death, completion of 3 years of treatment or patient's decision to discontinue, whichever occurs first.

Isatuximab will be given intravenously (IV) at the dose of 10 mg/kg on Days 1, 8, 15, 22 (cycle 1), 36, 50 (cycle 2), 64, 78 (cycle 3) and monthly thereafter (cycles 4-36).

Each cycle will be 28 days, after completion of third cycles, patients will continue with Isatuximab alone until disease progression, unacceptable AE, death, completion of 3 years of treatment or patient's decision to discontinue, whichever occurs first.

In vitro expanded and activated autologous NK cells

CellProtect

Naked immunoglobulin (Ig) G1 monoclonal antibody (mAb) that selectively binds to the human cell surface antigen molecule classified as cluster of differentiation (CD) 38

Isatuximab

Johan Lund, M.D.

Prospective, single center, randomized, open label, parallel group, 2-arm study assessing the clinical benefit in term of enhancement of overall response rate of Isatuximab in combination with CellProtect as compared to Isatuximab for the treatment of patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) as maintenance after SCT.

After confirmation of the eligibility criteria, patients will be randomly assigned in a 1:1 ratio to one of the two treatment arms:

Isatuximab in combination with CellProtect (ISA/CellProtect experimental arm), or Isatuximab (ISA, control arm).

Randomization will be at diagnosis and before the start of the treatment for patients eligible for SCT. Treatment administration will start within 100 days from AST date.

Patients will be treated until disease progression (max 3 years), unacceptable adverse event (AE), patient's decision to stop the study treatment, death or any other reasons, whichever occurs first.

Closing of randomization will occur after a total of approximately 60 patients have been randomized.

After randomisation, patients in experimental arm will donate starting material for the production of the IMP.

Manufacturing of CellProtect is promptly initiated for patients randomised to the active IMP arm A.

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

An Open, Randomised, Controlled, Phase II Trial of CellProtect in Combination With Isatuximab Antibody Versus Isatuximab Antibody Alone as Maintenance Treatment in Patients With Multiple Myeloma Undergoing High Dose Treatment

Evaluate in both arms the occurance after maintenance start of: Very good partial response (VGPR) or better rate, as defined by the International Myeloma Working Group (IMWG) criteria.

Assessment of changes in MRD negativity rate in patients with complete and very good partial response as well as conversion of MRD positivity to MRD negativity.

Assessment of treatment-emergent adverse events/serious adverse events (TEAEs/SAEs) (including IARs), laboratory parameters, vital signs, weight, ECOG PS, and findings from physical examination. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the treatment period.

The time from randomization to the date of first documentation of PD (as determined by the IRC using the IMWG criteria

The time from the date of the start of maintenance treatment to the date of documented progressive disease (PD) or death, whichever comes first.

The time from the date of the first IRC determined response to the date of first IRC PD or death, whichever occurs first. Duration of response will determined only for patients who have achieved CR, VGPR, or PR.

Spots Global Cancer Trial Database for sar650984

Every month we try and update this database with for sar650984 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sar650984

Every month we try and update this database with for sar650984 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sar650984 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.