Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
A:CPT+TD
B:TD
Sponsors
CCMU Beijing Chaoyang Hostipital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patient has a previous diagnosis of multiple myeloma, based on IMWG 2003definitions. All three of the following criteria must have been met: (1) Monoclonal immunoglobulin (M component) on electrophoresis, and onimmunofixation on serum or on total 24 hour urineb. Bone marrow (clonal) plasma cells >=10% or biopsy provenplasmacytomac. Related organ or tissue impairment (CRAB symptoms: anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections); 2. Patient with 2 prior lines of therapy who require retreatment of myeloma for one of the 2 conditions below: (1) Relapsed, defined by disease that recurred in a patient that respondedunder a prior therapy, by reaching a MR or better, and had notprogressed under this therapy nor up to 60 days of last dose of thistherapy. Patients priorly treated by BTZ may be eligible; (2) Relapsed-and-refractory to a therapy, provided that meets bothconditions: 1) patient has relapsed to at least one prior line 2) and patient was refractory to another line (except BTZ), by either notreaching a MR, or progressed while under this therapy, or within 60 daysof its last dose. 3. Patient has measurable disease on M protein at study screening defined byat least one of the following measurements as per thresholds clarified inIMWG 2003 disease definitions (Kyle, et al 2003): (1) Serum M-protein >=1 g/dL (>=10 g/L) (2) Urine M-protein >=200 mg/24h; 4. Patients treated with local radiotherapy with or without concomitant exposureto steroids for pain control or management of cord/nerve root compression,are eligible. Two weeks must have lapsed since last date of radiotherapy,which is recommended to be a limited field. Patients who require concurrentradiotherapy should have entry to the protocol deferred until the radiotherapyis completed and 2 weeks have passed since the last date of therapy; 5. Patient's age is >=18 years at time of signing the informed consent; 6. Patient has an Eastern Cooperative Oncology Group (ECOG) performancestatus (PS) of =1.0*10^9/L; (2) Platelet count >=50*10^9/L; (3) Serum potassium, magnesium, phosphorus, within normal limits (WNL)for institutiond. Total calcium (corrected for serum albumin) or ionized calcium >=LLN, and not higher than CTCAE grade 1 in case of elevated value. Note: Potassium, calcium, magnesium, and/or phosphorus supplements maybe given to correct values that are =60 ml/min; 8. Patient has provided written informed consent prior to any screeningprocedures; 9. Patient is able to swallow capsules.
Exclusion criteria
Exclusion criteria: 1. Patients who have progressed under all prior lines of anti MM therapy (primary refractory); 2. Patients who have been refractory to prior BTZ (ie. did not achieve at least a MR, or have progressed under it or within 60 days of last dose); 3. Allogeneic stem cell transplant recipient presenting with graft versus host disease either active or requiring immunosuppression; 4. Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug, following locally applicable prescribing information; 5. Patient has grade >=2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination within 14 days before randomization; 6. Patient received prior treatment with DAC inhibitors including panobinostat; 7. Patient needing valproic acid for any medical condition during the study or within 5 days prior to first administration of panobinostat/study treatment; 8. Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted only if commenced prior to the start of screening period); 9. Patient has another primary malignancy < 3 years from first dose of study treatment; 10. Patient who received: (1) prior anti-myeloma chemotherapy or medication including IMiDs and Dex <=3 weeks prior to start of study. (2) experimental therapy or biologic immunotherapy including monoclonal antibodies <=4 weeks prior to start of study. (3) prior radiation therapy <=4 weeks or limited field radiotherapy <=2 weeks prior start of study. 11. Patient has not recovered from all therapy-related toxicities associated with above listed treatments to < grade 2 CTCAE; 12. Patient has undergone major surgery <=2 weeks prior to starting study drug or who have not recovered from side effects of such therapy to < grade 2 CTCAE; 13. Patients with evidence of mucosal or internal bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;TTP;PFS; | — |
Countries
China
Contacts
Public ContactBing Zhu
Outcome results
None listed