Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged

Status Recruiting

Clinical Trial Summary

As optimal tolerance is the key for developing new treatments for the very elderly population, the aim of the study is to compare the efficacy and tolerance of isatuximab in combination with lenalidomide+dexamethasone (Rd) versus Rd only in very elderly patients aged 70 years or older. ln sum, a clear and clinically highly relevant benefit is expected with the isatuximab-based triple combination compared to the standard Rd doublet.

Clinical Trial Description

The treatment goals in elderly patients with multiple myeloma (MM) are similar to those in younger patients: rapid and long-lasting symptom control, deep response and durable remissions as well as increased survival are at the forefront, similar to therapy goals in younger patients. Elderly patients frequently present with comorbidities, reduced treatment tolerance and greater frequency of treatment discontinuations. Hence, treatment needs to be adapted to the specific needs of this patient population. ln the recent decade lenalidomide-based therapies have been established as effective treatment modalities in elderly patients. In elderly patients lenalidomide + dexamethasone (Rd) is one of the most frequently used treatment regimens, which is effective and well tolerated. MM is a high unmet medical need and as a result, several agents are currently under clinical investigation in MM. Monoclonal antibodies (mAb) are one of the most promising groups of drugs in development in the treatment of MM with several of them demonstrating activity in this disease. lsatuximab is a highly effective monoclonal antibody with an excellent activity and tolerance profile, active as single agent therapy in patients with multiple prior lines of treatment. Presently several trials with isatuximab-lenalidomide containing treatment regimens are ongoing. The expected benefits of adding isatuximab to Rd over Rd alone in very elderly patients seem to outweigh possible risks by far. A greater depth of response is anticipated including greater number of MRD (minimal residual disease) negative patients, higher response rates, and longer progression free survival. Risk conferred with the addition of isatuximab are mainly restricted to a roughly 40% rate of infusion reactions, which usually are seen at the first infusion only. ln addition, there is an increased risk for grade 4 leukopenia, grade 2 and 3 thrombocytopenia, and grade 3 infection and fatigue. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04891809
Study type	Interventional
Source	Arbeitsgemeinschaft medikamentoese Tumortherapie
Contact	Daniela Wolkersdorfer
Phone	+43 662640
Email	d.wolkersdorfer@agmt.at
Status	Recruiting
Phase	Phase 2
Start date	October 20, 2021
Completion date	December 2028

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See also
Status	Clinical Trial	Phase
Recruiting	`NCT04052880` - Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM	Phase 2
Active, not recruiting	`NCT03742297` - Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years	Phase 3
Not yet recruiting	`NCT05558319` - NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide	Phase 3
Not yet recruiting	`NCT05561049` - Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma
Completed	`NCT01936532` - Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06)	Phase 2
Recruiting	`NCT05259553` - Biomarkers in Multiple Myeloma	N/A
Completed	`NCT01809717` - Multiple Myeloma and Exercise	N/A
Withdrawn	`NCT04348006` - Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients	Phase 4
Terminated	`NCT03733691` - Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients	Phase 2
Active, not recruiting	`NCT00405756` - A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.	Phase 3
Recruiting	`NCT05665140` - Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients	Phase 2/Phase 3
Not yet recruiting	`NCT05088330` - A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM	N/A
Active, not recruiting	`NCT03948035` - Elotuzumab in Combination With Carfilzomib, Lenalidomide and Dexamethasone (E-KRd) Versus KRd in MM	Phase 3
Not yet recruiting	`NCT06348147` - Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation	Phase 2
Recruiting	`NCT06324266` - Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms