MedTrace Logo

To Compare Conservative Management Vs. Balloon Kyphoplasty in the Treatment of VCFs in Patients With Multiple Myeloma

NCT02732925 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-04-06

No results posted yet for this study

Summary

The purpose of this study is to determine whether surgical treatment, balloon kyphoplasty is more effective compared to conservative treatment alone (sham procedure) when assessing clinical, translational, radiological \& patient outcomes in patients with multiple myeloma.

Subjects will be recruited to the study if they have VAS score ≥ 6 and has given informed consent to participate in the Melody Study will be randomised to Arm 1 Sham Procedure and Conservative treatment or Arm 2 Balloon Kyphoplasty and Conservative treatment. Subjects recruited to Arm 1 (Sham Procedure and Conservative treatment) can cross over into Arm 2 (Balloon Kyphoplasty and Conservative Treatment) if they have a VAS score ≥ 6 between 8-12 weeks.

Conditions

Interventions

DEVICE

Arm 2 Balloon Kyphoplasty

Arm 2 Balloon Kyphoplasty (Medtronic LCC) and Conservative Treatment Subjects will be blinded and randomised to Arm 2 and will undergo a general anaesthetic and undergo a balloon kyphoplasty surgical procedure. They will also be treated with conservative management. Below is a list of the conservative management they will be managed by their Doctor: 1. Bisphosphonates 2. Pain relief 3. Systemic chemotherapy for Myeloma disease 4. Bed rest 5. Radiotherapy 6. Physiotherapy

PROCEDURE

Conservative Management

Patients recruited to Arm 1 and Arm 2 will undergo conservative management for Multiple Myeloma recommended by their Consultant Hematologist. * Concomitant treatment with bisphosphonates * Pain relief as required * Systemic chemotherapy for Myeloma disease * Bed rest * Radiotherapy * Physiotherapy

Sponsors & Collaborators

  • Royal National Orthopaedic Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Chara Kyriakou, MD PhD · RNOH

  • Sean Molloy, FRCS MSc · RNOH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2018-03-28
Completion
2018-03-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02732925 on ClinicalTrials.gov