Myeloma-Developing Regimens Using Genomics (MyDRUG)
MyDRUG
1 other identifier
interventional
103
1 country
16
Brief Summary
The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 25% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 25% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2019
Longer than P75 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 14, 2025
February 1, 2025
5.8 years
October 29, 2018
February 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Response Rate - Actionable Genetic Alteration
• To evaluate the overall response rate (ORR) with targeted agents used in combination with backbone regimen ixazomib, pomalidomide and dexamethasone (IPd) in patients with an actionable genetic alteration per the International Myeloma Working Group \[IMWG\] consensus criteria (Kumar et al, 2016)
Patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 years
Overall Response Rate - Non-Actionable Genetic Alteration
• To evaluate the ORR with agents used in combination with backbone (or IPd) regimen in patients with no actionable genetic alteration per IMWG consensus criteria (Kumar et al, 2016).
Patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 years
Study Arms (8)
Sub-Protocol A1
EXPERIMENTALPatients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Sub-Protocol B1
EXPERIMENTALPatients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Sub-Protocol C1
EXPERIMENTALPatients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Sub-Protocol D1
EXPERIMENTALPatients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Sub-Protocol E1
EXPERIMENTALPatients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Sub-Protocol Y1
EXPERIMENTALPatients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Sub-Protocol Y2
EXPERIMENTALPatients with Non-Actionable Genetic Abnormality receive Belantamab mafodotin in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Sub-Protocol Y3
EXPERIMENTALPatients with Non-Actionable Genetic Abnormality receive Selinexor in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Interventions
Patients with relapsed Multiple Myeloma will receive Abemaciclib and Dexamethasone for the first 2 cycles. Abemaciclib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Patients with relapsed Multiple Myeloma will receive Enasidenib and Dexamethasone for the first 2 cycles. Enasidenib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Patients with relapsed Multiple Myeloma will receive Cobimetinib and Dexamethasone for the first 2 cycles. Cobimetinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Patients with relapsed Multiple Myeloma will receive Erdafitinib and Dexamethasone for the first 2 cycles. Erdafitinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Eligibility Criteria
You may qualify if:
- Willing to be registered into the pomalidomide (POMALYST®) Risk Evaluation and Mitigation Strategy (REMS®) program
- Enrolled in the MMRF002 Molecular Profiling Protocol (NCT02884102) with report less than 120 days old
- Disease free of prior malignancies for ≥ 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or prostate cancer not requiring therapy
- High risk patients with relapsed refractory multiple myeloma (RRMM), who have:
- received at least one prior but no more than 3 prior therapies
- exposed to both a PI and an IMiD
- had early relapse after initial treatment Early relapse as defined by at least one of the following: (Relapse is defined as the IMWG uniform response)
- Relapse within 3 years of initiation of induction chemo therapy for post autologous stem cell transplantation (ASCT) followed by maintenance, or 18 months if unmaintained after ASCT
- Within 18 months of initial non-ASCT based therapy
- Patients must have progressed after their most recent treatment and require therapy for myeloma
- Females of reproductive potential must have a negative pregnancy test at baseline, be non-lactating, and willing to adhere to scheduled pregnancy testing
- Females of reproductive potential and males must practice and acceptable method of birth control
- Laboratory values obtained ≤ 14 days prior to registration:
- Absolute neutrophil count (ANC) ≥ 1000/ul
- Hemoglobin (Hgb) ≥ 8 g/dl
- +11 more criteria
You may not qualify if:
- Patients will be ineligible for this study if they meet any one of the following criteria:
- Aggressive multiple myeloma requiring immediate treatment as defined by:
- Lactate dehydrogenase (LDH) \> 2 times ULN
- Presence of symptomatic extramedullary disease or central nervous system involvement
- Hypercalcemia \>11.5 mg/dl
- Acute worsening of renal function (CrCl \< 30 ml/min) directly related to myeloma relapse
- Any neurological emergency related to myeloma
- Clinical symptoms of hyperviscosity related to monoclonal protein
- Involved serum free light chain \> 100 mg/dL (1000 mg/L) in the setting of prior diagnosis of cast nephropathy
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days of enrolment
- Known hypersensitivity or development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide, pomalidomide or similar drug. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of the agents
- Prior Ixazomib/Pomalidomide/Dexamethasone combination therapy
- Pregnant or breast-feeding females
- Serious medical or psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance, interfere in the completion of treatment per protocol, or follow-up evaluation
- Active hepatitis A, B or C viral infection or known human immunodeficiency virus (HIV) infection
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Multiple Myeloma Research Consortiumlead
- AbbViecollaborator
- Celgene Corporationcollaborator
- Eli Lilly and Companycollaborator
- Genentech, Inc.collaborator
- Janssen, LPcollaborator
- Takedacollaborator
- GlaxoSmithKlinecollaborator
- Karyopharm Therapeutics Inccollaborator
Study Sites (16)
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
City of Hope
Duarte, California, 91010, United States
Emory University
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Mayo Clinic - Minnesota
Rochester, Minnesota, 55905, United States
Washington University School of Medicine Division of Medical Oncology
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07610, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Ohio State University College of Medicine
Columbus, Ohio, 43210, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (1)
Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.
PMID: 27511158BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hearn J Cho, M.D., Ph.D.
Multiple Myeloma Research Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2018
First Posted
November 7, 2018
Study Start
April 1, 2019
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
February 14, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share