A Phase II Study of Daratumumab With Weekly Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? Daratumumab+Carfilzomib+Pomalidomide+Dexamethasone
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma. Relapsed and Refractory Multiple Myeloma is the condition of returned or previous treatment resistant Multiple Myeloma. This research study involves two study drugs and two standard of care drugs. * The names of the study drugs involved in this study are: * Carfilzomib * Daratumumab * The names of the standard of care drugs involved in this study are: * Dexamethasone * Pomalidomide

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Men or women ≥ 18 and ≤ 80 years old

• Diagnosis of multiple myeloma:

‣ Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval

⁃ ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis

⁃ Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio

• Previously treated relapsed and refractory multiple myeloma

‣ Patients must have received at least one prior line of therapy;

⁃ Prior therapy must include at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)

⁃ Disease progression on or within 60 days of completion of last therapy.

• ANC ≥ 1000/μL.

‣ G-CSF is not permitted within 14 days of screening.

⁃ Patients with ANC \<1000/µL can be considered for screening on a case by case basis with additional monitoring, after discussion with and approval from the PI.

• Platelet count ≥ 50,000/µL. Platelet transfusion is not permitted within 7 days of screening.

• Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.

• Calculated creatinine clearance of ≥ 30 mL/min by Cockcroft-Gault equation.

• Patient has adequate hepatic function, as evidenced by each of the following:

‣ Serum bilirubin values \< 2 mg/dL; and

⁃ Serum aspartate transaminase (ALT) and/or aspartate transaminase (AST) values \< 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \<3 mg/dL and normal direct bilirubin).

• Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin, apixaban, rivaroxaban, or equivalent.

• 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.

• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Pomalyst REMS program.

• A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug.

• Able to swallow capsules whole (pomalidomide capsules cannot be crushed, dissolved or broken).

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Andrew J Yee, MD
ayee1@mgh.harvard.edu
617-726-2000
Time Frame
Start Date: 2020-05-18
Estimated Completion Date: 2028-05
Participants
Target number of participants: 43
Treatments
Experimental: Daratumumab,Carfilzomib, Pomalidomide and Dexamethasone
Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment.~Participants will receive daratumumab, carfilzomib, pomalidomide, and dexamethasone on a 28 day schedule.~* Daratumumab will be given according to cycle and dosage determined by protocol.~* Carfilzomib will be given at 56 mg/m2 on days 1, 8, 15 (except for C1D1 where it is 20 mg/m2)~* Pomalidomide will be given daily on days 1-21.~* Dexamethasone will be given weekly, split over two days.
Related Therapeutic Areas
Sponsors
Collaborators: Amgen, Janssen Research & Development, LLC
Leads: Andrew Yee, MD

This content was sourced from clinicaltrials.gov

Similar Clinical Trials