- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04847453
Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis
A Phase 1/1a Study of Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for Relapsed/Refractory Light Chain Amyloidosis
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: Magnetic Resonance Imaging
- Drug: Venetoclax
- Procedure: Positron Emission Tomography
- Procedure: Computed Tomography
- Drug: Dexamethasone
- Drug: Ixazomib Citrate
- Procedure: Bone Marrow Aspiration and Biopsy
- Procedure: Biospecimen Collection
- Procedure: X-Ray Imaging
- Procedure: Transabdominal Ultrasound
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of venetoclax, MLN9708 (ixazomib citrate), and dexamethasone when used in combination.
II. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of venetoclax, MLN9708 (ixazomib citrate), and dexamethasone when used in combination.
SECONDARY OBJECTIVES:
I. To observe and record anti-tumor activity. II. To obtain a preliminary estimate of the anti-light chain amyloidosis (AL) activity as assessed by incidence of complete hematologic response (CR) and overall hematologic response (partial response [PR], very good partial response [VGPR], and CR).
III. To estimate the organ-specific response rates, among patients with measurable organ disease, using standard criteria.
IV. To estimate progression free survival.
EXPLORATORY OBJECTIVES:
I. To evaluate expression of BCL-2, BCL-XL, and MCL-1 on the surface of plasma cells of patients with AL.
II. To describe the immune profile in the peripheral blood of patients with AL before and during treatment with venetoclax, MLN9708 (ixazomib citrate), and dexamethasone at multiple time points.
III. To estimate hematologic response rates using mass spectrometry to detect persistence of a monoclonal protein in the serum and urine.
IV. To characterize the genotype of the CD138+ plasma cell in patients with AL and t(11;14) and compare findings to those of patients with multiple myeloma and t(11;14) as reported in prior studies.
V. To determine presence of minimal residual disease by Next Generation Sequencing (NGS) in patients achieving a hematologic CR.
OUTLINE: This is a dose-escalation study of venetoclax and ixazomib citrate.
Patients receive venetoclax orally (PO) once daily (QD) on days 1-28, ixazomib citrate PO on days 1, 8 and 15, and dexamethasone PO on days 1, 8, 15 and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo x-ray imaging and abdominal ultrasound during screening. Patients undergo bone marrow biopsy and/or aspiration as well as blood sample collection throughout the study. Patients may undergo computed tomography (CT) scans, and/or magnetic resonance imaging (MRI), and/or positron emission tomography (PET) scans throughout the study.
After completion of study treatment, patients are followed every 1-3 months until disease progression or death.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Michael A. Rosenzweig
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Comprehensive Cancer Center LAO
-
Contact:
- Michael A. Rosenzweig
- Email: mrosenzweig@coh.org
-
Principal Investigator:
- Michael A. Rosenzweig
-
Sacramento, California, United States, 95817
- Suspended
- University of California Davis Comprehensive Cancer Center
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University Hospital/Winship Cancer Institute
-
Principal Investigator:
- Craig C. Hofmeister
-
Contact:
- Site Public Contact
- Phone Number: 404-778-1868
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Principal Investigator:
- Carol A. Huff
-
Contact:
- Site Public Contact
- Phone Number: 410-955-8804
- Email: jhcccro@jhmi.edu
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
-
Principal Investigator:
- Giada Bianchi
-
Contact:
- Site Public Contact
- Phone Number: 877-442-3324
-
Boston, Massachusetts, United States, 02118
- Recruiting
- Boston Medical Center
-
Principal Investigator:
- Vaishali Sanchorawala
-
Contact:
- Site Public Contact
- Phone Number: 617-638-8265
-
-
New York
-
Bronx, New York, United States, 10461
- Recruiting
- Montefiore Medical Center-Einstein Campus
-
Principal Investigator:
- Nishi N. Shah
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center - Moses Campus
-
Principal Investigator:
- Nishi N. Shah
-
Contact:
- Site Public Contact
- Phone Number: 718-379-6866
- Email: eskwak@montefiore.org
-
Bronx, New York, United States, 10461
- Suspended
- Montefiore Medical Center-Weiler Hospital
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Principal Investigator:
- Naresh Bumma
-
Contact:
- Site Public Contact
- Phone Number: 800-293-5066
- Email: Jamesline@osumc.edu
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- University of Pittsburgh Cancer Institute (UPCI)
-
Principal Investigator:
- Kathleen A. Dorritie
-
Contact:
- Site Public Contact
- Phone Number: 412-647-8073
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute/University of Utah
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
Principal Investigator:
- Amandeep Godara
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Cancer Center
-
Principal Investigator:
- Laahn H. Foster
-
Contact:
- Site Public Contact
- Phone Number: 434-243-6303
- Email: uvacancertrials@hscmail.mcc.virginia.edu
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University/Massey Cancer Center
-
Contact:
- Site Public Contact
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Hashim Mann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically-proven systemic anti-light chain amyloidosis (AL) confirmed by positive Congo red staining with green birefringence on polarized light microscopy and evidence of a measurable clonal disease that requires active treatment. An underlying plasma cell disorder can be identified by one of the following: clonal plasma cells in the bone marrow (BM), monoclonal protein in the serum or urine, or abnormal free light chain ratio. For patients who are African-American or males >= 70 years with isolated cardiac involvement, mass spectrometry must be performed to confirm subtyping
- Presence of t(11;14) by fluorescence in situ hybridization (FISH) on bone marrow biopsy, either confirmed at screening or documented with a prior biopsy
- Patient requires therapy, as determined by the treating physician, following at least one line of treatment (No limit on the number of prior treatments)
- Age >= 18 years. Because no dosing or adverse event data are currently available on the use of venetoclax in combination with MLN9708 (ixazomib citrate) and dexamethasone in patients < 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,000/mcL. Screening absolute neutrophil count (ANC) should be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
- Platelets >= 75,000/mcL. Platelet transfusions to help patients meet eligibility criteria are not allowed within 2 weeks before study enrollment
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
- Creatinine Calculated clearance >= 15 mL/min using Cockcroft-Gault equation
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
AL Amyloidosis Cardiac Risk stage I, II or IIIa disease based on the 2013 European Modification of the 2004 Standard Mayo Clinic Staging in patients with advanced cardiac involvement (Dispenzieri et al., 2004; Wechalekar et al., 2013)
- Staging system defined by: NT-proBNP cut off of < 332 pg/mL and troponin I cut-off of < 0.10 ng/mL (in the absence of troponin T, troponin I >= 0.1 ng/mL can be used) as thresholds for stages I, II and III; NT-proBNP < 8500 pg/ml for stage IIIa
Stage I, both under threshold;
- Stage I: Zero markers above threshold: NT-proBNP < 332 ng/L AND troponin T (TnT) =< 0.035 ng/mL; NT-proBNP < 332 ng/L AND TnI =< 0.1 ng/mL
Stage II, either troponin or NT-proBNP (but not both) over threshold;
- Stage II: One marker above threshold: NT-proBNP >= 332 ng/L OR TnT >= 0.035 ng/mL; NT-proBNP >= 332 ng/L OR TnI >= 0.1 ng/mL
- Stage III, both over threshold;
Stage IIIa, both over threshold but NT-proBNP =< 8500 pg/ml
- Stage IIIa: Two markers above threshold: NT-proBNP >= 332 ng/L BUT =< 8,500 ng/L AND TnT >= 0.035 ng/mL; NT-proBNP >= 332 ng/L BUT =< 8,500 ng/L AND TnI >= 0.1 ng/mL
- Stage IIIb: Two markers above threshold: NT-proBNP > 8,500 ng/L AND TnT >= 0.035 ng/mL; NT-proBNP > 8,500 ng/L AND TnI >= 0.1 ng/mL
- Life expectancy >= 3 months
- Plasma cell burden =< 60%
- Absence of bone lesions and other end organ disease consistent with multiple myeloma (patients with plasma cell burden between 10 and 60% without end organ disease can be included)
- Measurable disease of AL amyloidosis as defined by at least one of the following: 1) serum or urine monoclonal protein >= 500 mg/dL by protein electrophoresis, or 2) serum free light chain >= 20 mg/L with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) >= 20 mg/L
It is not known what effects MLN9708 (ixazomib citrate), venetoclax, and dexamethasone have on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Nonsterilized female patients of reproductive age group and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below.
Female patients must meet 1 of the following:
- Postmenopausal for at least 1 year before the screening visit, or
- Surgically sterile, or
- If they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing of the informed consent form through 90 days after the last dose of study drug, or
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following:
- Practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or
- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception)
- Left ventricular ejection fraction >= 35% by echocardiogram.
- Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Exclusion Criteria:
- Patients who have had major surgery or radiotherapy within 14 days prior to entering the study. If the involved radiotherapy field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708 (ixazomib citrate)
- Patients who have had anti-plasma cell therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
- Patients who are receiving any other investigational agents, within 30 days of the start of this trial and throughout the duration of this trial
- Patients with central nervous system involvement
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax, MLN9708 (ixazomib citrate) (including boron or boron-containing products) or dexamethasone
- Strong or moderate CYP3A inhibitors (e.g., erythromycin, ciprofloxacin, diltiazem, fluconazole, verapamil), or strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort), or moderate CYP3A inducers (e.g., bosentan, efavirenz, etavirine) should be avoided
- Venetoclax should be administered using caution with substrates or inhibitors of P-glycoprotein (P-gp)
- Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active serious or systemic infection (within 14 days prior to study enrollment), active hepatitis B or C virus infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or myocardial infarction (within the past 6 months)
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Female patients who are lactating or have a positive serum pregnancy test during the screening period are excluded from this study because MLN9708 (ixazomib citrate) is a proteasome inhibitor with the potential for embryo-lethal effects, and an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MLN9708 (ixazomib citrate). Patients must stop breastfeeding while on MLN9708 (ixazomib citrate) and until 90 days have passed since their last dose. These potential risks may also apply to other agents used in this study
- Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of MLN9708 (ixazomib citrate), including difficulty swallowing
- Peripheral neuropathy that is >= grade 3, or grade 2 with pain on clinical examination during the screening period
- Patients that have previously been treated with MLN9708 (ixazomib citrate). Patients who have received prior treatment with venetoclax
- Patients without measurable disease by serum free light chain, serum m-spike or urine monoclonal protein
- Patients with New York Heart Association classification III/IV. Patients with advanced cardiac amyloidosis, Mayo stage IIIB based on European Modification of the 2004 Standard Mayo Clinic Staging in patients with advanced cardiac involvement with NT-Pro BNP > 8500 pg/mL (Wechalekar et al., 2013)
- Patients with grade 3 or worse diarrhea
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (venetoclax, ixazomib citrate, dexamethasone)
Patients receive venetoclax PO QD on days 1-28, ixazomib citrate PO on days 1, 8 and 15, and dexamethasone PO on days 1, 8, 15 and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients may undergo x-ray imaging and abdominal ultrasound during screening.
Patients undergo bone marrow biopsy and/or aspiration as well as blood sample collection throughout the study.
Patients may undergo CT scans, and/or MRI, and/or PET scans throughout the study.
|
Undergo MRI
Other Names:
Given PO
Other Names:
Undergo PET scan
Other Names:
Undergo CT scan
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Undergo bone marrow aspiration and biopsy
Undergo blood specimen collection
Other Names:
Undergo x-ray
Other Names:
Undergo transabdominal ultrasound
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 30 days
|
Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
|
Up to 30 days
|
Maximum tolerated dose
Time Frame: Up to the end of cycle 1
|
Defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate.
|
Up to the end of cycle 1
|
Recommended phase 2 dose (RP2D)
Time Frame: Up to the end of cycle 1
|
Will be based on the assessment of toxicities during cycle 1 that meet criteria for dose-limiting toxicities (DLT).
|
Up to the end of cycle 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (complete hematologic response)
Time Frame: After cycles 3, 6, 9, and 12, and every 6 months thereafter up to 2.5 years
|
Will be estimated based on the patients enrolled in the dose-escalation as well as the dose-expansion stage, using Clopper-Pearson confidence interval.
Hematologic complete response rate will be evaluated according to the consensus guidelines in treatment response.
|
After cycles 3, 6, 9, and 12, and every 6 months thereafter up to 2.5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expression of BCL-2, BCL-XL, BAX, BAK, BIM, NOXA, and MCL-1
Time Frame: Baseline
|
Will be assessed by immunohistochemistry.
|
Baseline
|
Immune profile in the peripheral blood
Time Frame: Before and during treatment
|
Will be determined by mass cytometry.
|
Before and during treatment
|
Hematologic response rates
Time Frame: Up to 2.5 years
|
Estimated using mass spectrometry to detect persistence of a monoclonal protein in the serum and urine.
|
Up to 2.5 years
|
Characterization of CD138+ plasma cell with t(11;14)
Time Frame: Up to 2.5 years
|
Up to 2.5 years
|
|
Presence of minimal residual disease
Time Frame: Up to 2.5 years
|
Will be determined by Next Generation Sequencing in patients achieving a hematologic complete response.
|
Up to 2.5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael A Rosenzweig, City of Hope Comprehensive Cancer Center LAO
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Paraproteinemias
- Proteostasis Deficiencies
- Neoplasms, Plasma Cell
- Immunoglobulin Light-chain Amyloidosis
- Amyloidosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dermatologic Agents
- Glycine Agents
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Venetoclax
- Ixazomib
- Glycine
- Ichthammol
Other Study ID Numbers
- NCI-2021-03038 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- UM1CA186717 (U.S. NIH Grant/Contract)
- 10440 (Other Identifier: CTEP)
- PHI-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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