A Safety and Efficacy Study of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT01464034 |
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Recruitment Status :
Recruiting
First Posted : November 3, 2011
Last Update Posted : October 18, 2017
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Sponsor:
Criterium, Inc.
Collaborators:
Amgen
Celgene Corporation
Information provided by (Responsible Party):
Criterium, Inc.
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Brief Summary:
This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Carfilzomib Drug: Pomalidomide Drug: Dexamethasone | Phase 1 Phase 2 |
This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy. The study will explore the efficacy of CPD including overall response, time to progression, progression free survival, and time to next therapy.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 117 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-Center Phase I/II, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma |
| Study Start Date : | November 2011 |
| Estimated Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | June 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Carfilzomib, Pomalidomide, Dexamethasone
All eligible subjects will receive the study intervention of Carfilzomib, Pomalidomide, and Dexamethasone.
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Drug: Carfilzomib
IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
Other Name: PR-171 Drug: Pomalidomide PO daily on Days 1-21, every 28 Days
Other Name: CC-4047 Drug: Dexamethasone 40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
Other Name: Decadron |
Primary Outcome Measures :
- Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Throughout treatment, estimated at 2-12 months per patient ]Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.
- Overall Response in Phase II [ Time Frame: Every 28 days while on treatment (estimated at 2- 12 months per patient) ]Overall Response (SD, MR, PR, VGPR, CR, sCR)
Secondary Outcome Measures :
- Overall Response in Phase I [ Time Frame: Every 28 days while on treatment (estimated at 2- 12 months per patient) ]Overall response (SD, MR, PR, VGPR, CR, sCR)
- Time to Progression [ Time Frame: Every 28 days while on treatment (estimated at 2-12 months per patient) ]
- Progression Free Survival [ Time Frame: throughout follow up (every 2-3 months for 2 years) ]
- Time to next therapy [ Time Frame: throughout follow up (every 2-3 months for 2 years) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cytopathologically or histologically confirmed dx of multiple myeloma
- Relapsed or refractory to the most recently received therapy.
- All pts must have received prior lenalidomide therapy and been determined to be refractory, relapsed, or intolerant.
- Measurable disease, as indicated by one or more of the following:
Serum M-protein ≥ 0.5 g/dL Urine Bence Jones protein ≥ 200 mg/24 hr Elevated Free Light Chain as per IMWG criteria, and abnormal ratio
- Pts must be ≥ 18 years of age
- Life expectancy of more than 3 months
- ECOG PS of 0-2
- Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN
- Uric acid must be within laboratory normal range
- CrCl ≥ 50 mL/min
- Additional Laboratory Requirements ANC ≥1.0 x 109/L Hgb ≥8 g/dL(transfusion permitted) Platelet count ≥50.0 x 109/L
- Screening 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
- Pts may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
- Screening platelet count should be independent of platelet transfusions for at least 2 weeks.
- Written informed consent in accordance with federal, local, and institutional guidelines
- FCBP must agree to ongoing pregnancy testing
- FCBP must have a negative serum or urine pregnancy test and agree to birth control.
- Male pts must agree to never have unprotected sexual contact with a female who can become pregnant and must agree to either completely abstain from sexual contact with females who are pregnant or are able to become pregnant. The patient must agree to inform his physician if he has had unprotected sexual contact with a female who can become pregnant or if he thinks for any reason that his sexual partner may be pregnant.
- Male pts cannot donate semen or sperm while taking pomalidomide and for 28 days after completing the study.
- All pts must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- Pts must agree to take enteric-coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE)at the investigator's discretion
Exclusion Criteria:
- Pts with known sensitivity to any immunomodulatory drugs (IMiDs)
- Use of any other experimental drug or therapy within 21 days prior to first dose
- Exposure to any prior chemotherapy, steroid use, or other myeloma treatment within 14 days prior to first dose. Pts currently on long term steroids do not require any washout period. in addition, steroid use for spinal cord compression is permitted and does not require a washout period.
- Radiation therapy within 14 days prior to first dose
- Known allergies to carfilzomib or Captisol
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Current diagnosis of plasma cell leukemia
- Waldenström's macroglobulinemia
- Major surgery within 21 days prior to first dose
- Pregnant or lactating females
- Congestive heart failure (NYHA class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months prior to first dose.
- Uncontrolled hypertension
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose
- Pts receiving active treatment or intervention for any other malignancy or pts who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
- Serious psychiatric or medical conditions that could interfere with treatment
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
- Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (e.g. lansoprazole), enteric-coated aspirin or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
- Pts in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g. due to pre-existing pulmonary, cardiac, or renal impairment
- Pts with primary systemic amyloidosis
- Pts who have received prior treatment with carfilzomib (Phase II only)
- Pts who have received prior treatment with pomalidomide (Phase II only)
- Pts who have received prior treatment with both carfilzomib & pomalidomide (Phase I only)
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): NCT01464034
Locations
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Yan Li 404-778-4713 yli9@emory.edu | |
| Principal Investigator: Jonathan Kaufman, MD | |
| United States, Indiana | |
| Indiana University Simon Cancer Center | Terminated |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New Jersey | |
| The John Theurer Cancer Center @ Hackensack UMC | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Laura Raucci 551-996-5683 lraucci@hackensackumc.org | |
| Principal Investigator: David Siegel, MD | |
| United States, New York | |
| Columbia University | Terminated |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Kimberly Oates, RN 919-668-6524 kimberly.bartlett@duke.edu | |
| Principal Investigator: Cristina Gasparetto, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania Abramson Cancer Center | Terminated |
| Philadelphia, Pennsylvania, United States, 19105 | |
| Fox Chase Cancer Center | Terminated |
| Philadelphia, Pennsylvania, United States, 19111 | |
| University of Pittsburgh Cancer Institute | Withdrawn |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: CR Study Reg Team 713-745-6130 jjshah@mdanderson.org | |
| Principal Investigator: Jatin Shah, MD | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Hermon Berhane hberhane@fredhutch.org | |
| Principal Investigator: Edward Libby, MD | |
Sponsors and Collaborators
Criterium, Inc.
Amgen
Celgene Corporation
Investigators
| Principal Investigator: | Jatin Shah, MD | AMyC | |
| Principal Investigator: | Brian GM Durie, MD | AMyC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Criterium, Inc. |
| ClinicalTrials.gov Identifier: | NCT01464034 History of Changes |
| Other Study ID Numbers: |
AMyC 10-MM-01 IST-CAR-521 ( Other Identifier: Onyx Pharmaceuticals ) PO-MM-PI-0034 ( Other Identifier: Celgene Corporation ) |
| First Posted: | November 3, 2011 Key Record Dates |
| Last Update Posted: | October 18, 2017 |
| Last Verified: | October 2017 |
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 acetate |
Dexamethasone Pomalidomide Thalidomide BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |