Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Relapsed and Refractory Multiple Myeloma
NCT ID: NCT02103335
Last Updated: 2017-11-22
Study Results
Results pending
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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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
38 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-06-05
Study Completion Date
2016-11-30
Brief Summary
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This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are:
* Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory drug) that has been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of multiple myeloma.
* Marizomib is an investigational drug being developed by Triphase that is being studied for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet been approved by health authorities, such as the FDA, for general use but have been approved for use in specific clinical studies. Marizomib inhibits a cellular machine called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome inhibitors have been shown to be effective in the treatment of multiple myeloma.
* Dexamethasone is a corticosteroid drug that affects the immune system (an immunomodulatory drug) that has been approved by the FDA for the treatment of multiple myeloma.
This is the first study to evaluate the three-drug combination of pomalidomide (POM), marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory multiple myeloma.
The primary objective of this study is to determine the best drug dosing levels for this three-drug combination, including the highest safe doses and/or the recommended doses for future clinical studies of this drug combination. The secondary purposes of this study are to determine the safety of this drug combination and its effectiveness in treating relapsed or refractory multiple myeloma. The study will include examination of levels of all three drugs in the blood during various time points during treatment.
* Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory drug) that has been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of multiple myeloma.
* Marizomib is an investigational drug being developed by Triphase that is being studied for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet been approved by health authorities, such as the FDA, for general use but have been approved for use in specific clinical studies. Marizomib inhibits a cellular machine called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome inhibitors have been shown to be effective in the treatment of multiple myeloma.
* Dexamethasone is a corticosteroid drug that affects the immune system (an immunomodulatory drug) that has been approved by the FDA for the treatment of multiple myeloma.
This is the first study to evaluate the three-drug combination of pomalidomide (POM), marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory multiple myeloma.
The primary objective of this study is to determine the best drug dosing levels for this three-drug combination, including the highest safe doses and/or the recommended doses for future clinical studies of this drug combination. The secondary purposes of this study are to determine the safety of this drug combination and its effectiveness in treating relapsed or refractory multiple myeloma. The study will include examination of levels of all three drugs in the blood during various time points during treatment.
Detailed Description
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Conditions
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Multiple Myeloma in Relapse
Refractory Multiple Myeloma
Multiple Myeloma
Keywords
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Myeloma
Multiple Myeloma
Pomalidomide
Marizomib
Low dose Dexamethasone
Relapsed
Refractory
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Single Group Assignment
Combination Pomalidomide, low-dose Dexamethasone, and Marizomib:
Group Type
EXPERIMENTAL
pomalidomide
Intervention Type
DRUG
Oral Pomalidomide, days 1-21 of 28 day cycle, dose 3 to 4 mg
marizomib
Intervention Type
DRUG
IV Marizomib, 0.2 to 0.5 mg/m2 on days 1, 4, 8, 11 of 28 day cycle
low-dose dexamethasone
Intervention Type
DRUG
Oral Dexamethasone, days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23 of 28 day cycle, 5 or 10 mg
Interventions
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pomalidomide
Oral Pomalidomide, days 1-21 of 28 day cycle, dose 3 to 4 mg
Intervention Type
DRUG
marizomib
IV Marizomib, 0.2 to 0.5 mg/m2 on days 1, 4, 8, 11 of 28 day cycle
Intervention Type
DRUG
low-dose dexamethasone
Oral Dexamethasone, days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23 of 28 day cycle, 5 or 10 mg
Intervention Type
DRUG
Other Intervention Names
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POMALYST
NPI-0052
Eligibility Criteria
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Inclusion Criteria
Subjects must meet the following criteria to be eligible for study participation:
1. At least 18 years at the time of signing the informed consent form.
2. Able to understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Documented diagnosis of multiple myeloma and measurable disease by serum or urine protein electrophoresis (SPEP or UPEP): SPEP ≥0.5 g/dL, UPEP ≥200 mg/24 hours, or involved serum free light chain (FLC) level ≥10 mg/dL provided the serum FLC ratio is abnormal.
5. Previously received 1 or more lines of anti-myeloma therapy that must have included both lenalidomide and bortezomib (either separately or in combination).
6. Documented disease progression during or within 60 days after their most recent line of anti myeloma therapy.
7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
8. All study participants in the USA must be registered into the mandatory POMALYST REMS™ (Risk Evaluation \& Mitigation Strategy) program, and be willing and able to comply with the requirements of the POMALYST REMS™ program.
9. All study participants in the USA who are females of child-bearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the POMALYST REMS™ program.
10. All study participants outside the USA must agree to comply with the POMALYST® PPRMP requirements.
11. All subjects must be able and agree to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
12. For females of child bearing potential (FCBP): Agree to use 2 reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study treatment, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation; must follow pregnancy testing requirements as outlined in the POMALYST REMS™ program or the PPRMP.
13. For all females: Agree to abstain from breastfeeding during study participation and for at least 28 days after study treatment discontinuation.
14. For all males: Agree to use a latex or synthetic condom during any sexual contact with FCBP while participating in the study and for at least 28 days following discontinuation from study treatment, even if he has undergone a successful vasectomy.
15. For all males: Agree to refrain from donating semen or sperm while on study and for at least 28 days after discontinuation from study treatment.
16. Refrain from donating blood while on study treatment and for at least 28 days after discontinuation from study treatment.
17. Agree not to share medication.
1. At least 18 years at the time of signing the informed consent form.
2. Able to understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Documented diagnosis of multiple myeloma and measurable disease by serum or urine protein electrophoresis (SPEP or UPEP): SPEP ≥0.5 g/dL, UPEP ≥200 mg/24 hours, or involved serum free light chain (FLC) level ≥10 mg/dL provided the serum FLC ratio is abnormal.
5. Previously received 1 or more lines of anti-myeloma therapy that must have included both lenalidomide and bortezomib (either separately or in combination).
6. Documented disease progression during or within 60 days after their most recent line of anti myeloma therapy.
7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
8. All study participants in the USA must be registered into the mandatory POMALYST REMS™ (Risk Evaluation \& Mitigation Strategy) program, and be willing and able to comply with the requirements of the POMALYST REMS™ program.
9. All study participants in the USA who are females of child-bearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the POMALYST REMS™ program.
10. All study participants outside the USA must agree to comply with the POMALYST® PPRMP requirements.
11. All subjects must be able and agree to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
12. For females of child bearing potential (FCBP): Agree to use 2 reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study treatment, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation; must follow pregnancy testing requirements as outlined in the POMALYST REMS™ program or the PPRMP.
13. For all females: Agree to abstain from breastfeeding during study participation and for at least 28 days after study treatment discontinuation.
14. For all males: Agree to use a latex or synthetic condom during any sexual contact with FCBP while participating in the study and for at least 28 days following discontinuation from study treatment, even if he has undergone a successful vasectomy.
15. For all males: Agree to refrain from donating semen or sperm while on study and for at least 28 days after discontinuation from study treatment.
16. Refrain from donating blood while on study treatment and for at least 28 days after discontinuation from study treatment.
17. Agree not to share medication.
Exclusion Criteria
Subjects with any of the following will be excluded from participation in the study:
1. Peripheral neuropathy Grade ≥2.
2. Non-secretory multiple myeloma.
3. Any of the following laboratory abnormalities:
* ANC \<1,000/µL;
* Platelet count \<50,000/µL for subjects in whom \<50% of bone marrow nucleated cells are plasma cells; or a platelet count \<30,000/µL for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells;
* Creatinine clearance (CrCL) \<45 mL/min as measured directly or as calculated according to Cockcroft Gault formula;
* Corrected serum calcium \>13.5 mg/dL (\>3.4 mmol/L);
* Hemoglobin \<8 g/dL (\<4.9 mmol/L; prior red blood cell \[RBC\] transfusion or recombinant human erythropoietin use is permitted before study entry);
* Serum aspartate aminotransferase (AST) \>3.0 x upper limit of normal (ULN);
* Serum alanine aminotransferase (ALT) \>3.0 x ULN;
* Serum total bilirubin \>1.5 x ULN (\>3.0 x ULN for subjects with known Gilbert's disease).
4. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥5 years. Subjects may be entered earlier than 5 years if they have received curative treatment for the following:
* Basal cell carcinoma of the skin;
* Squamous cell carcinoma of the skin;
* Carcinoma in situ of the cervix;
* Carcinoma in situ of the breast;
Or if they have:
o Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) or non metastatic prostate cancer that is in complete remission or does not require treatment.
5. Previous therapy with POM and/or MRZ.
6. History of allergic reaction or hypersensitivity to thalidomide, lenalidomide, bortezomib, carfilzomib, boron, mannitol, or DEX.
7. Grade ≥3 rash during prior thalidomide or lenalidomide therapy.
8. Gastrointestinal disease that may significantly alter the absorption of POM.
9. History of the following:
* Congestive heart failure of Class III or IV of the New York Heart Association (NYHA) classification;
* Myocardial infarction within 12 months prior to starting study treatment;
* Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.
10. Any of the following within 14 days prior to initiation of study treatment:
* Plasmapheresis;
* Major surgery (kyphoplasty is not considered major surgery);
* Radiation therapy;
* Anti-myeloma drug therapy.
11. Received any investigational agents within 28 days or 5 half-lives (whichever is longer) prior to initiation of study treatment.
12. Conditions requiring chronic steroid or immunosuppressive treatment (eg, rheumatoid arthritis, multiple sclerosis, or lupus), which likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
13. Subjects may not receive corticosteroids (\>10 mg/day of prednisone or equivalent) within 3 weeks prior to enrollment (use of steroidal inhalation aerosol for asthma is permitted).
14. Unable or unwilling to undergo antithrombotic prophylactic treatment.
15. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, as determined by the Investigator.
16. Pregnant and/or breastfeeding females.
17. Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
18. Known seropositive for or active viral infection with hepatitis B virus (HBV), with the following exceptions:
* negative are eligible.
* Subjects who had hepatitis B but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible.
* Subjects who are seropositive because of hepatitis B virus vaccine are eligible.
19. Known seropositive for or active viral infection with hepatitis C virus (HCV), with the following exception: Subjects who had hepatitis C but have received an antiviral treatment and show no detectable viral ribonucleic acid (RNA) for 6 months are eligible.
1. Peripheral neuropathy Grade ≥2.
2. Non-secretory multiple myeloma.
3. Any of the following laboratory abnormalities:
* ANC \<1,000/µL;
* Platelet count \<50,000/µL for subjects in whom \<50% of bone marrow nucleated cells are plasma cells; or a platelet count \<30,000/µL for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells;
* Creatinine clearance (CrCL) \<45 mL/min as measured directly or as calculated according to Cockcroft Gault formula;
* Corrected serum calcium \>13.5 mg/dL (\>3.4 mmol/L);
* Hemoglobin \<8 g/dL (\<4.9 mmol/L; prior red blood cell \[RBC\] transfusion or recombinant human erythropoietin use is permitted before study entry);
* Serum aspartate aminotransferase (AST) \>3.0 x upper limit of normal (ULN);
* Serum alanine aminotransferase (ALT) \>3.0 x ULN;
* Serum total bilirubin \>1.5 x ULN (\>3.0 x ULN for subjects with known Gilbert's disease).
4. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥5 years. Subjects may be entered earlier than 5 years if they have received curative treatment for the following:
* Basal cell carcinoma of the skin;
* Squamous cell carcinoma of the skin;
* Carcinoma in situ of the cervix;
* Carcinoma in situ of the breast;
Or if they have:
o Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) or non metastatic prostate cancer that is in complete remission or does not require treatment.
5. Previous therapy with POM and/or MRZ.
6. History of allergic reaction or hypersensitivity to thalidomide, lenalidomide, bortezomib, carfilzomib, boron, mannitol, or DEX.
7. Grade ≥3 rash during prior thalidomide or lenalidomide therapy.
8. Gastrointestinal disease that may significantly alter the absorption of POM.
9. History of the following:
* Congestive heart failure of Class III or IV of the New York Heart Association (NYHA) classification;
* Myocardial infarction within 12 months prior to starting study treatment;
* Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.
10. Any of the following within 14 days prior to initiation of study treatment:
* Plasmapheresis;
* Major surgery (kyphoplasty is not considered major surgery);
* Radiation therapy;
* Anti-myeloma drug therapy.
11. Received any investigational agents within 28 days or 5 half-lives (whichever is longer) prior to initiation of study treatment.
12. Conditions requiring chronic steroid or immunosuppressive treatment (eg, rheumatoid arthritis, multiple sclerosis, or lupus), which likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
13. Subjects may not receive corticosteroids (\>10 mg/day of prednisone or equivalent) within 3 weeks prior to enrollment (use of steroidal inhalation aerosol for asthma is permitted).
14. Unable or unwilling to undergo antithrombotic prophylactic treatment.
15. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, as determined by the Investigator.
16. Pregnant and/or breastfeeding females.
17. Known seropositive for or active viral infection with human immunodeficiency virus (HIV).
18. Known seropositive for or active viral infection with hepatitis B virus (HBV), with the following exceptions:
* negative are eligible.
* Subjects who had hepatitis B but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible.
* Subjects who are seropositive because of hepatitis B virus vaccine are eligible.
19. Known seropositive for or active viral infection with hepatitis C virus (HCV), with the following exception: Subjects who had hepatitis C but have received an antiviral treatment and show no detectable viral ribonucleic acid (RNA) for 6 months are eligible.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Celgene Corporation
INDUSTRY
Sponsor Role
collaborator
Celgene
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Steven D Reich, MD
Role: STUDY_DIRECTOR
Triphase Research and Development I Corp
Locations
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University of Chicago Medical Center
Chicago, Illinois, United States
Site Status
University of Maryland
Baltimore, Maryland, United States
Site Status
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
Karmanos Cancer Center
Detroit, Michigan, United States
Site Status
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Site Status
Alfred Hospital
Prahran, Victoria, Australia
Site Status
Countries
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United States
Australia
References
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Child JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, Brown J, Drayson MT, Selby PJ; Medical Research Council Adult Leukaemia Working Party. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med. 2003 May 8;348(19):1875-83. doi: 10.1056/NEJMoa022340.
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Mitsiades N, Mitsiades CS, Poulaki V, Chauhan D, Richardson PG, Hideshima T, Munshi NC, Treon SP, Anderson KC. Apoptotic signaling induced by immunomodulatory thalidomide analogs in human multiple myeloma cells: therapeutic implications. Blood. 2002 Jun 15;99(12):4525-30. doi: 10.1182/blood.v99.12.4525.
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BACKGROUND
Richardson PG, Jagannath S, Jakubowiak A, et al. Phase II Trial of Lenalidomide, Bortezomib, and Dexamethasone in Patients (pts) with Relapsed and Relapsed/Refractory Multiple Myeloma (MM): Updated Efficacy and Safety Data After > 2 Years of Follow-up. 2010b; ASH Annual Meeting Abstract #3049.
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BACKGROUND
Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
Reference Type
BACKGROUND
Wells PS, Anderson DR, Rodger M, Ginsberg JS, Kearon C, Gent M, Turpie AG, Bormanis J, Weitz J, Chamberlain M, Bowie D, Barnes D, Hirsh J. Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED D-dimer. Thromb Haemost. 2000 Mar;83(3):416-20.
Reference Type
BACKGROUND
Wells PS, Anderson DR, Rodger M, Forgie M, Kearon C, Dreyer J, Kovacs G, Mitchell M, Lewandowski B, Kovacs MJ. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003 Sep 25;349(13):1227-35. doi: 10.1056/NEJMoa023153.
Reference Type
BACKGROUND
Velcade® (bortezomib) for Injection Prescribing Information. Millennium Pharmaceuticals Inc., Cambridge, MA; V-12-0388 02/13. http://www.velcade-hcp.com/previously-untreated-multiple-myeloma/dosing.aspx?gclid=CPD4lKn2tbsCFcU5Qgod9R0AdA.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NPI-0052-107
Identifier Type: -
Identifier Source: org_study_id