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

NCT02732925 | Terminated DMC

• 1 other identifier: RNOH - Melody Study
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Myeloma

Keywords

Vertebral Compression Fracture; Balloon Kyphoplasty; Conservative treatment; Sham procedure; VCFs; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• the effect of sham procedure & conservative management alone (arm 1) versus balloon kyphoplasty (arm 2) on patient reported pain scores as assessed by VAS (at week 4)

  At week 4

Secondary Outcomes (5)

• the effect of conservative management alone versus balloon kyphoplasty on patient reported pain scores as assessed by VAS (at weeks 1, 8, 12, 16, 26, year 1 and year 2)

  At week 1, 8, 12, 26, year 1 and year 2

• the pain relief requirements of conservative management alone versus balloon kyphoplasty using a daily pain diary (capturing usage of pain relief by type)

  At week 1, 8, 12, 26, year 1 and year 2

• the effect of conservative management alone versus balloon kyphoplasty on patient reported Quality Of Life outcomes

  At week 1, 8, 12, 26, year 1 and year 2

• procedure related complications of conservative management alone versus balloon kyphoplasty

  At week 1, 8, 12, 26, year 1 and year 2

• the cost utility of the conservative management alone versus the balloon kyphoplasty

  at 2 years

Study Arms (2)

Arm 1 - Sham Procedure

SHAM COMPARATOR

Sham Procedure \& Conservative Treatment Subjects will be blinded and randomised to Arm 1 and will undergo a general anaesthetic and undergo a sham procedure. They will also be treated under conservative management alone. 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 This is a non interventional as conservative treatment (standard of care for multiple myeloma patients) is used.

Procedure: Conservative Management

Arm 2 - Balloon Kyphoplasty

ACTIVE COMPARATOR

Balloon Kyphoplasty \& Conservative Treatment - Interventional Arm Subjects will be blinded and randomised to Arm 2 (balloon kyphoplasty) 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 This is a interventional arm (balloon kyphoplasty procedure) and the patient will receive conservative treatment (standard of multiple myeloma patients) is used.

Device: Arm 2 Balloon Kyphoplasty; Procedure: Conservative Management

Interventions

Arm 2 Balloon Kyphoplasty DEVICE

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

Arm 2 - Balloon Kyphoplasty

Conservative Management PROCEDURE

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

Arm 1 - Sham Procedure; Arm 2 - Balloon Kyphoplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤80 years old
• Diagnosis of Multiple Myeloma
• Confirmed acute (MRI, a detectable low signal T1 ± oedema) painful vertebral compression fracture(s) VAS score is ≥6
• The patient is able to read and understand the Patient Information Sheet and study procedures
• The patient is able and willing to give written informed consent

You may not qualify if:

• Contraindications to anaesthesia
• Cord Compression or large epidural mass necessitating conservative management before balloon kyphoplasty
• Pain unrelated to vertebral collapse
• Infection at the site
• Presence of overt instability as judged by the principle investigator
• Known pregnancy at time of screening
• Severe Cardiopulmonary insufficiency
• Osteoblastic lesions
• Any co-morbidity, (e.g., diabetes, heart condition, obesity, psychiatric illness) which, in the opinion of the investigator, is of a severe enough nature to; interfere with the patient's ability to complete the study assessments; or present an unacceptable risk to the patient's safety to undergo study treatment

Sponsors & Collaborators

• Royal National Orthopaedic Hospital NHS Trust: lead

Study Sites (1)

Royal National Orthopaedic NHS Trust, Brockley Hill

Stanmore, UK, HA7 4LP, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chara Kyriakou, MD PhD

  RNOH

  PRINCIPAL INVESTIGATOR

• Sean Molloy, FRCS MSc

  RNOH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Innovation Centre

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: April 11, 2016
• Study Start: June 9, 2017
• Primary Completion: March 28, 2018
• Study Completion: March 28, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

GB (1)