Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 76 of 183 for:    carfilzomib OR pr-171

A Single Arm Study of Carfilzomib in Transplant Eligible High Risk Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02217163
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

Patients with high risk multiple myeloma have shorter remission periods and reduced overall survival. Prognostic significance of minimal residual disease negative remission is being highlighted in many of the newer studies.

The current phase 2 study investigates the combination of carfilzomib together with cyclophosphamide and dexamethasone in patients with high risk multiple myeloma in younger transplantation eligible patients.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Carfilzomib, Cyclophosphamide, Dexamethasone Phase 2

Detailed Description:

Carfilzomib is administered over 30 minutes as an infusion. For cycle 1 only, Carfilzomib is administered at 20mg/m2 IV on days 1 and 2, followed by escalation to 56mg/m2 on days 8,9,15 and 16 on a 28 day cycle. Patients who tolerate 56mg/m2 dose are kept at this dose for the subsequent cycles on Days 1,2,8,9,15,16 on a 28 day cycle. Dose and schedule modifications for intolerable side effects are detailed in the protocol. Additionally Cyclophosphamide is given a fixed dose of 500mg once per week orally, along with dexamethasone is given on the days of Carfilzomib administration, 30 minutes to 4 hours prior to Carfilzomib. Patients will undergo blood tests weekly and serum protein electrophoresis every 4 weeks during treatment.

Within completion of the 8 cycles of treatment patients would undergo stem cell collection using chemotherapy and growth factor mobilization. After completion of up to 8 cycles of treatment autologous bone marrow transplantation (BMT) will be conducted. Patients who achieve stringent CR before 8 cycles will undergo bone marrow biopsy for minimal residual disease (MRD) analysis by flow cytometry (MPFC). If MRD negativity by MPFC has been achieved, they may proceed directly to autologous BMT if possible, or if MRD positive, continue to complete 8 cycles of treatment and proceed to autologous BMT . Following bone marrow transplantation, there will be staging investigations including blood and bone marrow investigations and MRD analysis MPFC. Patients who achieve MRD negativity by MPFC will be managed expectantly by watch and wait. Patients who are MRD positive at this stage will undergo further consolidation and maintenance for 2 years or disease progression. Follow up would extend till a minimum of 2 years from completion of the study.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 2 SINGLE ARM STUDY OF CARFILZOMIB IN TRANSPLANT ELIGIBLE HIGH RISK MULTIPLE MYELOMA
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Myeloma treatment
The combination therapy with Carfilzomib, Cyclophosphamide and dexamethasone will be used to treat eligible patients for upto 8 cycles following which they will undergo autologous bone marrow transplantation. Following this there will disease assessment and further treatment decided afterwards.
Drug: Carfilzomib, Cyclophosphamide, Dexamethasone
Carfilzomib is administered over 30 minutes as an infusion. For cycle 1 only, Carfilzomib is administered at 20mg/m2 IV on days 1 and 2, followed by escalation to 56mg/m2 on days 8,9,15 and 16 on a 28 day cycle. Patients who tolerate 56mg/m2 dose are kept at this dose for the subsequent cycles on Days 1,2,8,9,15,16 on a 28 day cycle. Dose and schedule modifications for intolerable side effects are detailed in the protocol. Additionally Cyclophosphamide is given a fixed dose of 500mg once per week orally, along with dexamethasone is given on the days of Carfilzomib administration, 30 minutes to 4 hours prior to Carfilzomib.




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
    To study the progression free survival (PFS) in patients with newly diagnosed high risk multiple myeloma treated with Carfilzomib, Cyclophosphamide and Dexamethasone, followed by autologous bone marrow transplantation.


Secondary Outcome Measures :
  1. Minimal residual disease negativity [ Time Frame: 2 years ]
    Minimal residual disease burden at different time points, as assessed my multi parameter flow cytometry


Other Outcome Measures:
  1. Overall Survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed multiple myeloma AND Transplant eligible AND High Risk as defined by International staging system 3 OR Deletion 17p OR Amplification 1q OR transaction 4,14 OR translocation 14,16 OR translocation 14,20

Exclusion Criteria:

  1. Relapsed Myeloma
  2. Non Transplant eligible patient.
  3. Ig M subtype Myeloma
  4. POEMS syndrome
  5. Amyloidosis
  6. Waldenstroms Macroglobulinemia
  7. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days of randomization-Limited site radiation allowed.

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): NCT02217163


Locations
Layout table for location information
Singapore
National University Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yunxin Chen, MBBS Singapore General Hospital

Layout table for additonal information
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT02217163     History of Changes
Other Study ID Numbers: SGHMM1
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Dexamethasone acetate
Cyclophosphamide
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
Protease Inhibitors