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Experts Publish Treatment Recommendations For Multiple Myeloma-Related Bone Disease

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The International Myeloma Working Group, a group of leading myeloma special­ists, recently published its recommendations for the treatment of bone disease in multiple myeloma patients.

The researchers recommend that all myeloma patients receiving their first anti-myeloma therapy should also receive treatment with bis­phos­pho­nates, regard­less of whether the patient shows evidence of bone disease on x-rays. They also note that a minimally invasive procedure known as kypho­plasty, as well as low-dose radiation therapy, may be used to reduce severe pain or bone fractures.

In addition, they explain that most bisphosphonates are well tolerated, but patients may still require pre­ven­ta­tive strategies to avoid kidney damage and osteo­ne­crosis of the jaw, a rare but serious side effect of bis­phos­pho­nate treatment in which the blood supply to the jaw is lost, causing jaw­bone tissue to die.

Bone Disease And The Use Of Bisphosphonates

Bone disease is a common complication of multiple myeloma. Bone-destroying cells are more active in the bones of myeloma patients than bone-forming cells, which ultimately leads to bone destruction.

To slow down and prevent bone destruction, myeloma patients typically receive treatment with drugs known as bisphosphonates, which reduce the activity of the body’s bone-destroying cells. The most commonly prescribed bisphosphonates in multiple myeloma are Zometa (zoledronic acid) and Aredia (pamidronate).

The experts recommend that bisphosphonate treatment should be started in all multiple myeloma patients receiving anti-myeloma therapy, regardless of whether they show detectable bone lesions on x-rays, and in myeloma patients with osteoporosis or osteopenia (somewhat reduced bone density) resulting from myeloma.

The experts add, however, that it remains unclear whether treatment with bisphosphonates has a clinical benefit in patients who do not show bone lesions on magnetic resonance imaging (MRI) or positron emis­sion tomography/computed tomography (PET-CT).

In patients with active, or symptomatic, myeloma, the experts explain that both Zometa and Aredia are equal­ly effective in reducing bone pain and delaying the time to the first bone lesion or fracture.

They further note that Zometa has been shown in a large clinical trial to be superior to the oral bisphos­pho­nate Bonefos (clodronate; not sold in the United States) in terms of preventing fractures and in terms of overall survival, and that Zometa should therefore be preferred to Bonefos.

The recommendations are unclear, however, as to whether Zometa should be considered the preferred bisphosphonate for treating myeloma patients.

On the one hand, the text of the recommendations includes no specific statement describing Zometa as a preferred bisphosphonate.

There are, on the other hand, regular statements noting, for example, that Zometa “is the only bis­phos­pho­nate shown to increase survival in the whole studied population of a prospective randomized trial” — a ref­er­ence to the trial in which Zometa was found to be superior to Bonefos.

In addition, a summary table near the end of the recommendations describes Zometa and Aredia as the “first option” and “second option,” respectively, for the treatment of newly diagnosed myeloma patients requiring anti-myeloma treatment.

In patients with smoldering, or asymptomatic, myeloma, the experts note that both Zometa and Aredia re­duce the risk of developing bone disease, but neither slow progression to multiple myeloma. Thus, they suggest that low- and intermediate-risk asymptomatic patients who have osteoporosis be treated with bis­phos­phonates at doses used for osteoporosis. For patients with high-risk smoldering myeloma and bone loss that may be myeloma-related, especially if the patients have abnormal MRIs, the experts recom­mend using bisphosphonates at the doses used for symptomatic myeloma.

According to the experts, patients with the myeloma precursor disease monoclonal gammopathy of un­de­termined significance (MGUS) are at a higher risk for developing osteoporosis. The authors, however, do not recommend that all MGUS patients be treated with bisphosphonates.  Instead, they indicate that MGUS patients with osteoporosis should be treated with bisphosphonates at doses typically used for patients with osteoporosis.

Timing And Administration Of Bisphosphonate Treatment

The experts recommend intravenous administration of bisphosphonates every three to four weeks in pa­tients receiving the drugs during or after anti-myeloma therapy.

Treatment with Zometa should be administered until disease progression for patients who do not achieve a very good partial or complete response to their anti-myeloma therapy, and should be continued after re­lapse.

According to the experts, the evidence is less clear regarding the duration of therapy with Aredia. They therefore recommend that physician discretion determine the duration of treatment with Aredia, and that treatment be resumed at relapse.

The researchers add that the optimal treatment duration is not clear for patients who achieve a very good partial or complete response to their anti-myeloma therapy. The experts recommend, however, that these patients be treated for at least 12 months and up to 24 months and at their physicians’ discretion thereafter.

The experts note that further studies are being conducted to assess the long-term efficacy of reduced bis­phos­pho­nate doses in multiple myeloma.

Side Effects Of Bisphosphonates

The recommendations note that bisphosphonates are generally well tolerated and doses can be adjusted based on a patient’s response to the drug.

Common treatment-related side effects include low calcium levels, injection site reactions, and stomach problems.

To prevent low calcium levels, the experts recommend that patients receive calcium and vitamin D3 on a daily basis. However, they point out that calcium supplementation should be used with caution in patients with kidney impairment.

The experts also recommend that physicians monitor patients for the development of serious complications, such as kidney failure and osteonecrosis of the jaw.

To prevent kidney failure, the experts advise that kidney function be measured in patients before each bis­phos­pho­nate infusion, and that patients with mild to moderate kidney impairment should receive reduced doses of bisphosphonates.

To prevent osteonecrosis of the jaw, patients treated with bisphosphonates should maintain good dental hygiene and stop bisphosphonate treatment for 90 days before and after invasive dental procedures.

Alternative Treatment Options For Bone Disease

The new recommendations also address several other options for myeloma patients with bone disease that are intended to reduce severe pain or bone fractures.

Kyphoplasty is a minimally invasive procedure in which a physician inserts and inflates a small balloon into the fractured vertebra, creating a space that is then filled with an acrylic cement to stabilize the spinal cord. Vertebroplasty is a procedure in which the cement is injected directly into the fractured vertebra.

According to the experts, kyphoplasty is the treatment of choice to improve the quality of life of patients with fractured vertebrae. They state that the benefits of vertebroplasty are less clear because randomized trials of vertebroplasty have not been carried out yet in myeloma patients.

Radiation therapy may also be used for pain reduction and localized improvements in function. However, the experts advise that it should only be used in urgent cases, depending on a patient’s prior treatment history and response, due to its impact on bone marrow function.

More invasive surgeries are treatment options for the repair of certain fractures, such as fractures of the long bones, spinal cord compression, or vertebral column instability.  The experts recommend that patients consult with both their hematologist and an orthopedic surgeon to determine how the surgery may impact the administration of their myeloma therapy.

For more information, please refer to the International Myeloma Working Group’s full recommendations in the Journal of Clinical Oncology (abstract).


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