Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
103 participants
INTERVENTIONAL
2019-04-01
2024-12-31
Brief Summary
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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).
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Detailed Description
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* 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. Relapse is defined as the IMWG uniform response criteria (Kumar et al, 2016). Early relapse as defined by at least one of the following:
1. Relapse within 3 years post autologous stem cell transplantation (ASCT) on maintenance, or 18 months if unmaintained
2. Relapse within 18 months of initial non-ASCT based therapy
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sub-Protocol A1
Patients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Abemaciclib, dexamethasone, ixazomib, pomalidomide
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.
Sub-Protocol B1
Patients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Enasidenib, dexamethasone, ixazomib, pomalidomide
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.
Sub-Protocol C1
Patients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Cobimetinib, dexamethasone, ixazomib, pomalidomide
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.
Sub-Protocol D1
Patients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Erdafitinib, dexamethasone, ixazomib, pomalidomide
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.
Sub-Protocol E1
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.
Venetoclax, dexamethasone, ixazomib, pomalidomide
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.
Sub-Protocol Y1
Patients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Daratumumab, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Sub-Protocol Y2
Patients with Non-Actionable Genetic Abnormality receive Belantamab mafodotin in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Sub-Protocol Y3
Patients with Non-Actionable Genetic Abnormality receive Selinexor in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Selinexor, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Interventions
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Abemaciclib, dexamethasone, ixazomib, pomalidomide
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.
Enasidenib, dexamethasone, ixazomib, pomalidomide
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.
Cobimetinib, dexamethasone, ixazomib, pomalidomide
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.
Erdafitinib, dexamethasone, ixazomib, pomalidomide
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.
Venetoclax, dexamethasone, ixazomib, pomalidomide
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.
Daratumumab, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Selinexor, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
1. 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
2. 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
* Platelet (PLT) ≥ 75,000/ul
* Total bilirubin \<1.5 x upper limit of normal (ULN) or if total bilirubin is \>1.5 x ULN, the direct bilirubin must be ≤ 2.0 mg/dL
* Aspartate aminotransferase (AST) \<3 x ULN
* Creatinine Clearance ≥ 30 mL/min
Measurable disease of Multiple Myeloma (MM) as defined by at least one of the following:
* Serum monoclonal protein ≥ 0.5 g by protein electrophoresis
* ≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis
* Serum immunoglobulin free light chain (FLC) ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio
* Monoclonal bone marrow plasmacytosis ≥30% (evaluable disease)
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
* Ability to take aspirin, warfarin, or low molecular weight heparin
Exclusion 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
* Concurrent symptomatic amyloidosis or plasma cell leukemia
* POEMS syndrome \[plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes\]
* Residual side effects to previous therapy \> Grade 1 prior to initiation of therapy (Alopecia any grade and/or neuropathy Grade 2 without pain are permitted)
* Prior allogeneic or ASCT within 12 weeks of initiation of therapy. Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD)
* Prior experimental therapy within 14 days of protocol treatment or 5 half-lives of the investigational drug, whichever is longer
* Prior anticancer therapy within 14 days of initiation of protocol therapy (Dexamethasone/ 40mg/day) for a maximum of 4 days before screening is allowed
* Prior major surgical procedure or radiation therapy within 4 weeks of the initiation of therapy (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of therapy).
* Known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or Gastro Intestinal (GI) absorption of drugs administered orally
* Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
* Other co-morbidity, which would interfere with patient's ability to participate in trial or that confounds the ability to interpret data from the study
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Celgene Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
Genentech, Inc.
INDUSTRY
Janssen, LP
INDUSTRY
Takeda
INDUSTRY
GlaxoSmithKline
INDUSTRY
Karyopharm Therapeutics Inc
INDUSTRY
Multiple Myeloma Research Consortium
NETWORK
Responsible Party
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Principal Investigators
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Hearn J Cho, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Multiple Myeloma Research Consortium
Locations
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Mayo Clinic - Arizona
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Mayo Clinic - Minnesota
Rochester, Minnesota, United States
Washington University School of Medicine Division of Medical Oncology
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Ohio State University College of Medicine
Columbus, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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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.
Other Identifiers
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MyDRUG (MMRC-085)
Identifier Type: -
Identifier Source: org_study_id
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