Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide,

Status Recruiting

Clinical Trial Summary

This is a single center, open-label, phase 2 study in elderly (age ≥ 70) subjects with newly diagnosed multiple myeloma who are transplant ineligible. Subjects will receive subcutaneous daratumumab, dose-attenuated bortezomib, revlimid, and dexamethasone until confirmed disease progression, discontinuation of study treatment due to unacceptable drug toxicity, or other reasons. Throughout the study, subjects will be monitored closely for adverse events, laboratory abnormalities, and clinical response.

Clinical Trial Description

This is a single center, open-label, phase 2 study in elderly (age ≥ 70) subjects with newly diagnosed multiple myeloma who are transplant ineligible. The main study consists of the following phases: a 28-day screening phase; followed by initial therapy with 12 cycles of daratumumab in combination with dose-attenuated VRd; and a maintenance phase that starts after Cycle 12 of therapy. Cycles are 28 days in length. Treatment can continue until disease progression or unacceptable toxicity. After 12 cycles of initial therapy, maintenance therapy will begin with 28 day cycles of daratumumab with either lenalidomide or ixazomib and the choice of maintenance therapy will be based on cytogenetic risk status at diagnosis. All subjects will continue maintenance treatment until disease progression, except maintenance daratumumab will be discontinued after 2 years if subjects remain on maintenance treatment at that time. All subjects will be followed in the longterm follow-up for at least 1 year after last dose of study treatment and will continue until death, withdrawal of consent for study participation, or the end of study definition is met. The end of study is defined as when all subjects have completed at least 1 year of long-term follow up and until death, withdrawal of consent for study participation, or 5 years after first patient begins daratumumab therapy, whichever occurs first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04052880
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact	Larysa Sanchez
Phone	(212) 241-4705
Email	larysa.sanchez@mountsinai.org
Status	Recruiting
Phase	Phase 2
Start date	October 24, 2019
Completion date	June 2025

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See also
Status	Clinical Trial	Phase
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
Recruiting	`NCT04891809` - Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM	Phase 2
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.

Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms