A trial comparing treatments for myeloma (MRC Myeloma IX)

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

• Melphalan and prednisolone (MP)
• Cyclophosphamide tablets, thalidomide and dexamethasone (CTDa)

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

People having thalidomide had more side effects such as pins and needles, drowsiness, constipation and skin rash.

The average length of time that people lived overall was similar whether they had maintenance thalidomide or not. But the researchers also looked at chromosomes in the myeloma cells. This is called cytogenetics . They classified people as having ‘favourable’ or ‘adverse’ cytogenetics. They found that on average, people with favourable cytogenetics did live longer if they had thalidomide maintenance therapy. So having thalidomide maintenance treatment improves progression free survival and for some people, it can improve overall survival.

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 (peer reviewed ) and published in medical journals. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.