"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial comparing treatments for myeloma (MRC Myeloma IX)
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This trial was comparing different treatment combinations for people with myeloma.
Doctors usually treat multiple myeloma with chemotherapy. Those who are younger and fitter often have more intensive treatment. This means high dose chemotherapy with a stem cell or bone marrow transplant.
People with myeloma may also have one of a group of drugs called bisphosphonates. Bisphosphonates help to prevent bone fractures and bone pain in people with myeloma. They may also help to treat the disease.
People may have bisphosphonates such as clodronate (Bonefos) or pamidronate. In this trial doctors compared clodronate to another bisphosphonate called zoledronic acid (Zometa, or zoledronate) to see which was better.
Thalidomide has been shown to slow the growth of myeloma cells. But doctors weren’t sure at what stage people should have thalidomide, what dose they should have, or how long they should have it for. In this trial some people had thalidomide straight away, alongside chemotherapy. Some had thalidomide after other treatment (maintenance therapy), and some didn’t have thalidomide at all.
The aims of this trial were to
- Compare new combinations of drugs including thalidomide with treatments already used to see which worked best
- Compare zoledronic acid with clodronate to see which worked best
- Find out how well low dose thalidomide worked as maintenance treatment
Summary of results
The trial team found that
- Newer drug combinations that include thalidomide were better than other drug combinations
- Zoledronic acid not only helped to prevent bone damage, but also increased the average length of time people lived
- Having thalidomide maintenance treatment after chemotherapy helped people to stay free of myeloma for longer
The trial recruited 1,970 people. It was a randomised trial. The people taking part were put into treatment groups by computer. Neither they nor their doctor could decide which groups they were in.
According to how fit they were, they initially had 1 of 4 chemotherapy treatment plans. There were 2 types of intensive treatment chemotherapy
- Cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD)
- Cyclophosphamide, thalidomide and dexamethasone (CTD)
And 2 types of non intensive chemotherapy
The researchers looked at the number of people whose myeloma completely disappeared (a complete response) and the number whose myeloma got a bit better (a partial response).
Of the people having intensive therapy, those who had a complete response or a very good partial response was
- 28 out of every 100 (28%) in the CVAD group
- 43 out of every 100 (43%) in the CTD group
The number of people having non intensive therapy who had a complete response or very good partial response was
- 4 out of every 100 (4%) in the MP group
- 30 out of every 100 (30%) in the CTDa group
Everybody taking part was also randomised to have either zoledronic acid or clodronate with their chemotherapy. Overall, the average length of time that people lived was
- 50 months for those who had zoledronic acid
- 44½ months for those who had clodronate
And the average length of time that people lived without any signs of their myeloma getting worse was
- 19½ months for people who had zoledronic acid
- 17½ months for people who had clodronate
The side effects of the 2 bisphosphonate drugs were similar, but 4% of the people having zoledronic acid developed a rare condition called osteonecrosis of the jaw, compared to less than 1% of the people having clodronate.
After having chemotherapy, 818 of the people taking part were randomised again. Half had thalidomide maintenance therapy and half did not.
The trial team looked at how long these people lived without any signs of their myeloma getting worse (researchers call this progression free survival).
Of the people who’d had intensive chemotherapy, the average length of time was
- 30 months for people who had thalidomide maintenance therapy after chemotherapy
- 23 months for people who didn’t have maintenance therapy
Of the people who’d had non intensive chemotherapy, it was
- 11 months for people who had thalidomide maintenance therapy after chemotherapy
- 9 months for people who didn’t have maintenance therapy
The average length of time that people lived overall was similar whether they had maintenance thalidomide or not. But the researchers also looked at
Overall, the researchers concluded that treatments with newer drug combinations and zoledronic acid had the best response rates. They suggested that people should start having zoledronic acid when they are diagnosed with myeloma.
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
Professor J Anthony Child
Professor Gareth Morgan
Dr Graham Jackson
Chugai Pharma UK Ltd
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
National Institute for Health Research Cancer Research Network (NCRN)
Schering Healthcare Ltd