DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Pomalidomide and Dexamethasone With Growth Factor Support

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myeloma

Intervention: Pomalidomide (Drug); Dexamethasone (Drug); G-CSF (Drug); Phone Calls (Behavioral)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Michael Wang, MD,MS, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Michael Wang, MD, MS, Phone: 713-792-2860

Summary

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given in combination with dexamethasone and neupogen (filgrastim) to patients with relapsed or refractory MM. The goal of Part 2 of this study is to learn if the drug combination can help to control MM. The safety of this drug combination will be studied in both parts.

Clinical Details

Official title: A Phase I/II Study of Pomalidomide and Dexamethasone With Growth Factor Support in Patients With Relapsed/Refractory Multiple Myeloma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD) of Pomalidomide with Dexamethasone and Growth Factor Support

Secondary outcome: Overall Response

Detailed description: Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 7 groups of up to 6 participants each will be enrolled in Part 1 of the study and up to 19 participants will be enrolled in Part 2. Induction Phase: If you are enrolled in Part 1, the dose of pomalidomide you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of pomalidomide. Each new group will receive a higher dose of pomalidomide than the group before it, if no intolerable side effects were seen. Up to 7 dose levels will be studied. If you are enrolled in Part 2, you will receive pomalidomide at the highest dose that was tolerated in Part 1. All participants will receive the same dose level of dexamethasone and filgrastim. The induction phase will last for 6 cycles. Maintenance Phase: After Cycle 6, participants in both parts will enter the maintenance phase. You will receive a lower dose of pomalidomide then you were receiving during induction. You will receive the same dose level of dexamethasone that you were receiving during induction. You will not receive filgrastim during the maintenance phase. Study Drug Administration: Each cycle is 28 days. During Induction:

- You will take pomalidomide by mouth on Days 1-21.

- You will take dexamethasone by mouth on Days 1, 8, 15, and 22.

- You will receive filgrastim through a needle under the skin on Days 22-28.

During Maintenance:

- You will take pomalidomide by mouth on Days 1-21 of every cycle.

- You will take dexamethasone by mouth on Days 1, 8, 15, and 22 of every cycle.

If you miss a dose of pomalidomide, take it as soon as you can that same day. If you miss a day completely, do not make up the dose up the next day. If you take more than your prescribed dose of pomalidomide, seek emergency medical care, if needed, and contact your study doctor right away. Pomalidomide should be taken without food, at least 2 hours before or 2 hours after a meal. You or your caregiver will be given instructions on how to administer the filgrastim injection at home. Study Visits: Induction Phase: On Day 1 of Cycles 1-6:

- You will have a physical exam.

- You will have a neurological exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- Blood (about 1 teaspoon) and/or urine will be collected to check the status of the

disease. If urine is collected, you will collect the urine over a 24-hour period.

- You will be provided with a container to collect the urine in.

- If you can become pregnant, you will have a blood (about 1½ tablespoons) or urine

pregnancy test. On Days 8, 15, and 22 of Cycles 1-6:

- Blood (about 2 tablespoons) will be drawn for routine tests.

- If you can become pregnant, you will have a blood (about 1½ tablespoons) or urine

pregnancy test. Maintenance Phase: On Day 1 of every cycle:

- You will have a physical exam. You will have a neurological exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- Blood (about 1 teaspoon) and/or urine will be collected to check the status of the

disease. If urine is collected, you will collect the urine over a 24-hour period. You will be provided with a container to collect the urine in.

- If your doctor thinks it is needed, you will have a bone marrow biopsy and/or

aspiration to check the status of the disease.

- If you can become pregnant, you will have a blood (about 1½ tablespoons) or urine

pregnancy test.

- If you were found to have plasmacytomas at screening, you may have CT scans, PET/CT

scans, or MRI to measure them. If you are not at MD Anderson, the routine blood draws can be done at your regular doctor's office. Length of Study: You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over once you have completed your long-term follow-up. End-of-Study Drug Visit: After you finish taking the study drugs:

- You will have a physical exam.

- You will have a neurological exam.

- You will have an EKG.

- Blood (about 2 teaspoons) and urine will be collected for routine tests and to check

your thyroid.

- Blood (about 1 teaspoon) will be drawn to check how well your blood clots.

- Blood (about 1 teaspoon) and/or urine will be collected to check the status of the

disease. If urine is collected, you will collect the urine over a 24-hour period. You will be provided with a container to collect the urine in.

- If your doctor thinks it is needed, you will have x-rays of your entire body to check

for any bone fractures or tumors in the bone.

- If you can become pregnant, you will have a blood (about 1½ tablespoons) or urine

pregnancy test.

- If you were found to have plasmacytomas at screening, you may have CT scans, PET/CT

scans, or MRI to measure them. Long Term Follow-Up: After your end-of-study drug visit, you will be called every 3 months for 1 year and every 6 months after that to see how you are doing. These calls will take about 2-3 minutes. This is an investigational study. Pomalidomide is FDA approved and commercially available for the treatment of multiple myeloma in patients whose disease has not gotten worse within 60 days after receiving at least 2 prior therapies (including lenalidomide and bortezomib).The combination of pomalidomide, dexamethasone, and filgrastim to treat MM is investigational. The study doctor can explain how the study drug(s) are designed to work. Up to 55 participants will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Relapsed and/or refractory multiple myeloma with measurable disease, as defined by one or both of the following (assessed within 14 days prior to initiation of therapy): a. Serum M-protein>/= 0. 5 g/d; b. Urine Bence-Jones protein >/= 200 mg/24 hours. 2. Patients with light chain only myeloma are eligible. The involved free light chain level >/= 100 mg/L with abnormal serum free light chain ratio. 3. Patients must have prior treatment with >/= 2 cycles of lenalidomide and >/= 2 cycles of bortezomib (either in separate regimens or as part of the same regimen) (primary refractory of subjects refractory to the most recent regimen are eligible) 4. The patient has received /= 18 years

6. Eastern Cooperative Oncology Group performance status 0 - 2

7. Adequate hepatic function, with serum ALT < 3. 5 times the upper limit of normal and serum direct bilirubin < 2 mg/dL (34 Omol/L) within 7 days of time of consent. 8. Absolute neutrophil count (ANC) >/= 1. 0 × 10^9/L within 7 days of time of consent, without granulocyte-colony stimulating factor (G-CSF). 9. Hemoglobin > 9 g/dL (80 g/L) within 7 days of time of consent (subjects may be receiving red blood cell transfusions in accordance with institutional guidelines) 10. Platelet count > 100 × 10^9/L. 11. Creatinine clearance > 50 mL/minute within 7 days of time of consent, either measured or calculated using a standard formula (e. g., Cockcroft and Gault) 12. Written informed consent in accordance with federal, local, and institutional guidelines 13. All study participants must be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program. 14. Females of childbearing potential (FCBP) must have a negative serum or urine

pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again

within 24 hours prior to starting Cycle 1 of pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing and follow pregnancy testing requirements as outlined in the POMALYST REMS program. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Exclusion Criteria: 1. Hypersensitivity to previous lenalidomide or thalidomide. 2. History of serious allergic reactions to pegfilgrastim or filgrastim. 3. Chemotherapy (approved or investigational) within 3 weeks prior to signing consent. 4. Antibody therapy within 6 weeks prior to signing consent. 5. Radiotherapy to >/= 3 sites at the same time within 1 week prior to signing consent 6. Immunotherapy within 28 days prior to signing consent. 7. Pregnant or breast feeding females 8. Major surgery within 21 days prior to signing consent. 9. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to signing consent. 10. Known human immunodeficiency virus infection 11. Known Active hepatitis B or C infection 12. Unstable angina or myocardial infarction within 4 months prior to registration, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker 13. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to signing consent. 14. Non-hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas

15. Significant neuropathy (Grades 3 - 4, or Grade 2 with pain) within 14 days prior to

signing consent. 16. Subjects with known or likely systemic amyloidosis 17. Ongoing graft-vs.-host disease 18. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.

Locations and Contacts

Michael Wang, MD, MS, Phone: 713-792-2860

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: March 2014
Last updated: June 30, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017