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Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax in Treating Patients With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03701321
Recruitment Status : Suspended (Other - FDA Partial Clinical Hold)
First Posted : October 10, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase I/II trial studies the side effects and best dose of venetoclax when given together with daratumumab, bortezomib, and dexamethasone, and how well they work in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as venetoclax and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving venetoclax with daratumumab, bortezomib, and dexamethasone may work better in treating patients with relapsed or refractory multiple myeloma compared to standard of care treatment, including chemotherapy.

Condition or disease Intervention/treatment Phase
Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Drug: Bortezomib Biological: Daratumumab Drug: Dexamethasone Drug: Venetoclax Phase 1 Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 arms in phase I, 2 arms in phase II
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Daratumumab, Bortezomib, Dexamethasone With or Without Venetoclax in Relapsed/Refractory Multiple Myeloma With Assessment for t(11;14) Status
Actual Study Start Date : January 25, 2019
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023


Arm Intervention/treatment
Experimental: Phase I (DVd, venetoclax)
Patients receive daratumumab IV on days 1, 8, and 15 of cycles 1-3 and on day 1 of subsequent cycles, bortezomib SC on days 1, 8, and 15 of cycles 1-8, dexamethasone PO on days 1, 8, and 15 of cycles 1-8, and venetoclax PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Bortezomib
Given SC
Other Names:
  • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
  • LDP 341
  • MLN341
  • PS-341
  • PS341
  • Velcade

Biological: Daratumumab
Given IV
Other Names:
  • Anti-CD38 Monoclonal Antibody
  • Darzalex
  • HuMax-CD38
  • JNJ-54767414

Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex

Drug: Venetoclax
Given PO
Other Names:
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclexta
  • Venclyxto

Experimental: Phase II Arm D (DVd, venetoclax)
Patients receive venetoclax PO QD on days 1-21, daratumumab IV on days 1, 8, and 15 of cycles 1-3 and on day 1 of subsequent cycles, bortezomib SC on days 1, 8, and 15 of cycles 1-8, and dexamethasone PO on days 1, 8, and 15 of cycles 1-8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Bortezomib
Given SC
Other Names:
  • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
  • LDP 341
  • MLN341
  • PS-341
  • PS341
  • Velcade

Biological: Daratumumab
Given IV
Other Names:
  • Anti-CD38 Monoclonal Antibody
  • Darzalex
  • HuMax-CD38
  • JNJ-54767414

Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex

Drug: Venetoclax
Given PO
Other Names:
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclexta
  • Venclyxto

Active Comparator: Phase II Arm E (DVd)
Patients receive daratumumab IV on days 1, 8, and 15 of cycles 1-3 and on day 1 of subsequent cycles, bortezomib SC on days 1, 8, and 15 of cycles 1-8, and dexamethasone PO on days 1, 8, and 15 of cycles 1-8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Bortezomib
Given SC
Other Names:
  • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
  • LDP 341
  • MLN341
  • PS-341
  • PS341
  • Velcade

Biological: Daratumumab
Given IV
Other Names:
  • Anti-CD38 Monoclonal Antibody
  • Darzalex
  • HuMax-CD38
  • JNJ-54767414

Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex




Primary Outcome Measures :
  1. Maximum tolerated dose of venetoclax in combination with daratumumab, bortezomib and dexamethasone (Phase I) [ Time Frame: Up to 35 days ]
    Highest dose at which fewer than one-third of patients experience a dose-limiting toxicity.

  2. Minimal residual disease (MRD) negative status (Phase II) [ Time Frame: After cycle 8 ]
    Per revised International Myeloma Working Group (IMWG) response criteria for next-generation sequencing (NGS) methods.


Secondary Outcome Measures :
  1. Overall survival (OS) (Phase II) [ Time Frame: From randomization to death due to any cause, or censored at the date last known alive, assessed up to 10 years ]
    OS distributions will be estimated using Kaplan-Meier (KM) methods and compared between treatment arms with the log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate. Median OS by treatment arm with 95% confidence intervals will be reported.

  2. Progression-free survival (PFS) (Phase II) [ Time Frame: From randomization until the earlier of progression or death due to any cause, or censored at date of last disease evaluation, assessed up to 10 years ]
    PFS distributions will be estimated using KM methods and compared between treatment arms with the log-rank test. Stratified cox proportional hazards regression will produce a treatment hazard ratio estimate. Median PFS by treatment arm with 95% confidence intervals will be reported.

  3. Best response (Phase II) [ Time Frame: Up to cycle 8 ]
    Will be based on standard IMWG criteria. Response will be tabulated by category. Response rates of very good partial response or better will be compared using the Fisher's exact test.

  4. Time to progression (TTP) (Phase II) [ Time Frame: From randomization to progression, or censored at the date of last disease evaluation, assessed up to 10 years ]
    TTP in each arm will be estimated using Kaplan-Meier methods and compared between arms with the log-rank test.

  5. Incidence of adverse events (Phase II) [ Time Frame: Up to 10 years ]
    Will be assessed per Common Terminology Criteria for Adverse Events version 5.0. Will compare worst grade 3 or higher non-hematologic and overall treatment-related toxicity rates between arms using the Fisher's exact test.


Other Outcome Measures:
  1. Duration of treatment (Phase II) [ Time Frame: From time of randomization to date off treatment, or censored at date of last treatment, assessed up to 10 years ]
    Treatment duration in each arm based on submission of the off-treatment case report form will be estimated using Kaplan-Meier methods and compared between arms with the log-rank test.

  2. Cumulative dose (Phase II) [ Time Frame: Up to 10 years ]
    Defined as the sum of all doses taken across all cycles. Descriptive statistics will be used to assess exposure to all drugs separately based on calculations for cumulative dose, dose intensity, and relative dose intensity.

  3. Dose intensity (Phase II) [ Time Frame: Up to 10 years ]
    Calculated as cumulative dose received divided by treatment duration. Descriptive statistics will be used to assess exposure to all drugs separately based on calculations for cumulative dose, dose intensity, and relative dose intensity.

  4. Relative dose intensity (Phase II) [ Time Frame: Up to 10 years ]
    Calculated as the dose intensity divided by planned dose intensity. Descriptive statistics will be used to assess exposure to all drugs separately based on calculations for cumulative dose, dose intensity, and relative dose intensity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PHASE I (ARMS A, B, C) - STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must have been diagnosed with symptomatic relapsed/refractory multiple myeloma.

    • NOTE: Relapsed/refractory myeloma is defined as a disease which becomes non-responsive or progressive on therapy or within 60 days of the last treatment in patients who had achieved a minimal response (MR) or better on prior therapy.
  • PHASE I (ARMS A, B, C) - STEP 1: t(11;14) status must be determined.
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must not have bortezomib refractory disease. Prior lenalidomide refractory patients are allowed.
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must have been treated with 1 or more lines of therapy. 1 prior line of systemic therapy is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy). Auto stem cell transplant is allowed provided the patient is 100 days out from stem cell infusion. Patients must not have had prior venetoclax. Allogeneic stem cell transplantation (SCT) patients are excluded.
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must have measurable disease as defined by having one or more of the following, obtained within 14 days prior to randomization:

    • >= 0.5 g/dL monoclonal protein (M-protein) on serum protein electrophoresis.
    • >= 200 mg/24 hrs of monoclonal protein (M-protein) on a 24 hour urine protein electrophoresis.
    • Involved free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65).
  • PHASE I (ARMS A, B, C) - STEP 1: Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay are required to be performed within 14 days prior to randomization.

    • NOTE: UPEP (on a 24 hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr and urine in addition to serum must be followed in order to confirm a very good partial response (VGPR) or higher response.
    • NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike >= 0.5 g/dL. Measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr.
  • PHASE I (ARMS A, B, C) - STEP 1: Platelet count >= 100,000 cells/mm^3 (within 14 days prior to randomization).
  • PHASE I (ARMS A, B, C) - STEP 1: Absolute neutrophil count >= 1000 cells/mm^3 (within 14 days prior to randomization).
  • PHASE I (ARMS A, B, C) - STEP 1: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the upper limit of normal (within 14 days prior to randomization).
  • PHASE I (ARMS A, B, C) - STEP 1: Total bilirubin =< 1.5 x the upper limit of normal (within 14 days prior to randomization).
  • PHASE I (ARMS A, B, C) - STEP 1: Calculated creatinine clearance >= 30 mL/min (within 14 days prior to randomization).
  • PHASE I (ARMS A, B, C) - STEP 1: Hemoglobin >= 8.0 g/dL (within 14 days prior to randomization).
  • PHASE I (ARMS A, B, C) - STEP 1: Women must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol. All females of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • PHASE I (ARMS A, B, C) - STEP 1: Women of childbearing potential and sexually active males must use an accepted and highly effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 3 months after the last dose of daratumumab or 30 days after the last dose of venetoclax, whichever is longer. Male patients must also agree not to donate sperm for the duration of their participation in the study for 3 months after the last dose of daratumumab or 30 days after the last dose of venetoclax whichever is longer.
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must not have > grade 2 neuropathy and/or a syndrome characterized by polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin change (POEMS).
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must not have New York Heart Association (NYHA) class III or IV heart failure or myocardial infarction within 6 months prior to registration.
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must avoid concomitant use of venetoclax with moderate or strong CYP3A inhibitors, strong or moderate CYP3A inducers, P-glycoprotein (P-gp) inhibitors, or narrow therapeutic index P-gp substrates.
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must not be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Patients with resolved infection (i.e., patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HepB) deoxyribonucleic acid (DNA) levels. Those who are PCR positive are not eligible. Patients with serologic findings suggestive of HepB vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HepB vaccination, do not need to be tested for HepB DNA by PCR. Patients with HepB core antibody (cAb) positive but HepB sAg negative, as well as HepB PCR negative, are eligible but will need to be monitored throughout the study.
  • PHASE I (ARMS A, B, C) - STEP 1: Patients must not be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
  • PHASE II (ARMS D, E) - STEP 1: ECOG performance status of 0-2.
  • PHASE II (ARMS D, E) - STEP 1: Patients must have been diagnosed with symptomatic relapsed/refractory multiple myeloma.

    • NOTE: Relapsed/refractory myeloma is defined as a disease which becomes non-responsive or progressive on therapy or within 60 days of the last treatment in patients who had achieved a minimal response (MR) or better on prior therapy.
  • PHASE II (ARMS D, E) - STEP 1: t(11;14) status must be determined.
  • PHASE II (ARMS D, E) - STEP 1: Patients must not have bortezomib refractory disease. Prior lenalidomide refractory patients are allowed.
  • PHASE II (ARMS D, E) - STEP 1: Patients must have been treated with 1 or more lines of therapy. 1 prior line of systemic therapy is defined as 1 or more planned cycles of single agent or combination therapy, as well as a planned series of treatment regimens administered in a sequential manner (e.g. lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide maintenance therapy would be considered 1 line of prior therapy). Auto stem cell transplant is allowed provided the patient is 100 days out from stem cell infusion. Patients must not have had prior venetoclax. Allogeneic SCT patients are excluded.
  • PHASE II (ARMS D, E) - STEP 1: Patients must have measurable disease as defined by having one or more of the following, obtained within 14 days prior to randomization:

    • >= 0.5 g/dL monoclonal protein (M-protein) on serum protein electrophoresis.
    • >= 200 mg/24 hours (hrs) of monoclonal protein (M-protein) on a 24 hour urine protein electrophoresis.
    • Involved free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65).
  • PHASE II (ARMS D, E) - STEP 1: SPEP, UPEP, and serum FLC assay are required to be performed within 14 days prior to randomization.

    • NOTE: UPEP (on a 24 hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr. Please note that if both serum and urine m-components are present, both must be followed in order to evaluate response.
    • NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike >= 0.5 g/dL. Measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr.
  • PHASE II (ARMS D, E) - STEP 1: Platelet count >= 100,000 cells/mm^3 (within 14 days prior to randomization).
  • PHASE II (ARMS D, E) - STEP 1: Absolute neutrophil count >= 1000 cells/mm^3 (within 14 days prior to randomization).
  • PHASE II (ARMS D, E) - STEP 1: AST and ALT =< 2.5 x the upper limit of normal (within 14 days prior to randomization).
  • PHASE II (ARMS D, E) - STEP 1: Total bilirubin =< 1.5 x the upper limit of normal (within 14 days prior to randomization).
  • PHASE II (ARMS D, E) - STEP 1: Calculated creatinine clearance >= 30 mL/min (within 14 days prior to randomization).
  • PHASE II (ARMS D, E) - STEP 1: Hemoglobin >= 8.0 g/dL (within 14 days prior to randomization).
  • PHASE II (ARMS D, E) - STEP 1: Women must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol. All females of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • PHASE II (ARMS D, E) - STEP 1: Women of childbearing potential and sexually active males must use an accepted and highly effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 3 months after the last dose of daratumumab or 30 days after the last dose of venetoclax, whichever is longer. Male patients must also agree not to donate sperm for the duration of their participation in the study for 3 months after the last dose of daratumumab or 30 days after the last dose of venetoclax, whichever is longer.
  • PHASE II (ARMS D, E) - STEP 1: Patients must not have > grade 2 neuropathy and/or POEMS.
  • PHASE II (ARMS D, E) - STEP 1: Patients must not have NYHA Class III or IV heart failure or myocardial infarction within 6 months prior to registration.
  • PHASE II (ARMS D, E) - STEP 1: Patients must avoid concomitant use of venetoclax with moderate or strong CYP3A inhibitors, strong or moderate CYP3A inducers, P-gp inhibitors, or narrow therapeutic index P-gp substrates.
  • PHASE II (ARMS D, E) - STEP 1: Patients must not be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Patients with resolved infection (i.e., patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HepB) DNA levels. Those who are PCR positive are not eligible. Patients with serologic findings suggestive of HepB vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HepB vaccination, do not need to be tested for HepB DNA by PCR. Patients with HepB cAb positive but HepB sAg negative, as well as HepB PCR negative, are eligible but will need to be monitored throughout the study.
  • PHASE II (ARMS D, E) - STEP 1: Patients must not be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy). However, patients who test negative for HepC by PCR may participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701321


Locations
Layout table for location information
United States, Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael A Thompson ECOG-ACRIN Cancer Research Group

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03701321     History of Changes
Other Study ID Numbers: NCI-2018-02131
NCI-2018-02131 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAA172 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
EAA172 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
URL: https://grants.nih.gov/policy/sharing.htm

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Bortezomib
Venetoclax
Daratumumab
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists