Myeloma IX - Non-Intensive Pathway

How is this trial run?

This trial is known as a randomised control trial. A randomised control trial is a trial in which patients with similar disease traits are selected by a computer to be placed in different groups that are comparing different treatments. There is no way at the time for your doctor or nurse to know which of the treatments is best and neither you nor your doctor get to choose which treatment you have. The choice of treatments will be made by a computer. The computer has no information about you as an individual.

Introduction

This trial looks at four things in three phases;

Phase One: Induction Phase
This phase compares two combinations of chemotherapy, and two types of bisphosphonate treatment.

Phase Two: Maintenance Phase
This phase compares receiving a drug called thalidomide after your main treatment is over with the standard treatment of no further drugs.

Induction Phase

Firstly, the trial aims to compare two standard induction chemotherapy treatments called MP and CTDa and two bisphosphonate drugs called Clodronate which is given as a tablet and Zoledronic acid which is given through a drip into your vein. bisphosphonate drugs can really help with some of the symptoms of your myeloma.

The drugs which make up MP are:

The MP chemotherapies are taken as tablets. To complete a course of MP will take about four days. Each full course is called a cycle and is repeated every four weeks, usually for six to nine cycles.

The drugs which make up CTDa are:

All of the CTDa drugs are given as tablets. To complete a course of CTDa will take about three weeks. Each full course is called a cycle and is repeated every three weeks, usually for six to nine cycles.

So there are four combinations of drugs that you could be possibility be allocated to receive:

A: Clodronate & MP

B: Zoledronic Acid & MP

C: Clodronate & CTDa

D: Zoledronic Acid & CTDa

Your doctors expect your disease to respond well to any of the four combinations of drugs. However, if by the third cycle of treatment your disease is not responding as well as expected your doctor may replace your chemotherapy with an alternative treatment called Velcade (or bortezomib) and dexamethasone.

The Maintenance Phase

Your disease will have the best response somewhere between the sixth and ninth cycle of chemotherapy. This is called the Maximal Response and the timing is different for different people. When your doctor decides that you have had the best response possible to your chemotherapy you will enter the second phase of the trial called the Maintenance Phase.

At this point, regardless of which group you were in for either your chemotherapy or your bisphosphonate treatment you will be randomly allocated to one of the two different groups in this phase.

If you are in the first group you will not receive any further treatment but will be carefully monitored by the doctor. Your doctor will physically examine you regularly and make a point of closely observing your condition.

If you are in the second group will be given a low dose of a drug called thalidomide. The doses of thalidomide will begin as soon as the Maximal Response occurs and continue until you and your doctor decide otherwise. Thalidomide is taken as a tablet.

What might stop me from entering this trial?

You won't be asked to enter this trial for the following reasons:

• You are not experiencing any symptoms from your myeloma
• You have a solitary myeloma lesion in either your bone or soft tissue but no other signs of disease
• You have had previous treatment for your myeloma apart from local radiotherapy, bisphosphonate treatment or low doses of steroids
• If you have a serious medical condition
• If you are pregnant
• If you have had cancer in the last 5 years, apart from surgically removed non-melanoma skin cancer or other in situ carcinomas

What might being entered in this trial mean to me?

Tests and hospital visits

Before you enter the trial you will have a number of tests. This will tell your health care team about your general health and whether you are eligible for the trial or not.

The investigations may include:

During this trial you will come to the hospital as an outpatient every four weeks at first but this will gradually reduce to three monthly. This will be organized by your doctor or nurse.