NCT02217163

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 transplant-eligible patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Oct 2014

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

6 years

First QC Date

August 12, 2014

Last Update Submit

October 15, 2020

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    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.

    2 years

Secondary Outcomes (2)

  • Minimal residual disease negativity

    2 years

  • Overall Survival (OS)

    2 years

Study Arms (1)

Single Arm

EXPERIMENTAL

The combination therapy of Carfilzomib, cyclophosphamide and dexamethasone (KCyd) will be used to treat eligible patients for up to 6 cycles.This will be followed by an autologous bone marrow transplantation and 2 further consolidation cycles of KCyd. Depending on their disease response, patients will be managed expectantly or be started on maintenance.

Drug: Carfilzomib, , Cyclophosphamide, Dexamethasone

Interventions

Carfilzomib, , Cyclophosphamide, DexamethasoneDRUG

Carfilzomib is administered intraveneously over 30 minutes. For cycle 1 only, Carfilzomib is administered at 20mg/m2 on Day 1 and 2, dose will be escalated to 36mg/m2 on Day 8,9,15 and 16 of the 28-days cycle. Patients who tolerate the 36mg/m2 dose are kept at this dose for the subsequent cycles on Day 1,2,8,9,15,16 on a 28 days cycle. Cyclophosphamide is given at a fixed dose of 500mg once per week orally, along with dexamethasone which is given on the days of Carfilzomib administration, 30 minutes to 4 hours prior to Carfilzomib infusion.

Also known as: Kyprolis
Single Arm

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed Multiple Myeloma AND Transplant eligible AND
  • High Risk as defined by:
  • International Staging System 3 OR
  • FISH abnormality of t(4,14), t(14;16), 17p deletion or 1q amp
  • Patients must have evaluable myeloma, with at least one of the following (Assessed within 28 days of commencing the study)
  • Serum M protein \>/= 0.5g/dL or
  • Urine M protein \>200mg/24hr
  • Serum free light chains \>100mg/mL (involved light chain) and abnormal k/l ratio
  • For IgA patients who have no other means of measurement of disease, sIgA level \>0.75g/dL

You may not qualify if:

  • Relapsed Myeloma
  • Non transplant eligible patient.
  • IgM subtype Myeloma
  • POEMS syndrome
  • Amyloidosis
  • Waldenstroms Macroglobulinemia
  • Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days of randomization (Limited site radiation allowed).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomibCyclophosphamideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Chandramouli Nagarajan, MBBS

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

SG(2)