What is the mechanism of action of this treatment?

Common treatments for Multiple Myeloma (MM) often target bone health due to the disease's impact on bone density. Romosozumab, a monoclonal antibody, inhibits sclerostin to promote bone formation and decrease bone resorption, which is vital for managing bone density and reducing skeletal-related events (SREs) in MM patients. Other treatments like bisphosphonates and denosumab work by inhibiting osteoclast-mediated bone resorption, thereby reducing bone pain and the risk of fractures. These mechanisms are crucial for maintaining bone integrity and improving the quality of life for MM patients.

What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma that focus on bone health, such as bisphosphonates (e.g., zoledronic acid) and denosumab, share side effects like osteonecrosis of the jaw, hypocalcemia, and atypical fractures. Bisphosphonates may also cause nephrotoxicity, flu-like symptoms, and ocular toxicities, while denosumab can increase the risk of infections. Romosozumab, a monoclonal antibody, has been associated with injection site reactions, cardiovascular events, and rare cases of osteonecrosis of the jaw and atypical femoral fractures.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including monoclonal antibodies and other agents that target bone health. Denosumab, a RANKL inhibitor, is approved for the treatment of bone disease in Multiple Myeloma by inhibiting osteoclast-mediated bone resorption. Bisphosphonates like zoledronic acid and pamidronate are also approved to reduce skeletal-related events in Multiple Myeloma patients. While romosozumab itself is being studied for its effects on bone formation and resorption in Multiple Myeloma, it is not yet FDA-approved for this specific condition.

What other types of research exist?

Promising alternatives to Romosozumab for Multiple Myeloma patients include bisphosphonates (such as zoledronic acid and pamidronate) and denosumab. These agents are effective in reducing skeletal-related events and improving bone density. Additionally, investigational approaches like multitargeted kinase inhibitors (e.g., regorafenib, cabozantinib) may offer some benefit, though further data is needed.

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Monoclonal Antibodies

Romosozumab for Osteoporosis in Multiple Myeloma

Phase 1

Waitlist Available

Led By Carlyn Tan, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma

Presence of any one or more myeloma defining events such as evidence of end organ damage attributed to the underlying plasma cell proliferative disorder

Must not have

History of non-healed dental or oral surgery

History of cardiovascular event (myocardial infarction and/or stroke) within the past 12 months of study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing romosozumab, a medication that helps build and strengthen bones, in postmenopausal people with multiple myeloma. These patients often have weak bones due to osteoporosis and bone disease related to their condition. Romosozumab works by promoting new bone growth and preventing bone loss. Romosozumab is a recently approved monoclonal antibody that promotes bone formation and prevents bone resorption.

Who is the study for?

This trial is for postmenopausal women with multiple myeloma and osteoporosis. Participants must be over 18, able to follow study procedures, have documented MM, and show signs of bone weakness or fractures. They can't join if they've had certain treatments recently, have low vitamin D (unless corrected), abnormal calcium levels, a history of jawbone problems or recent serious heart events.

What is being tested?

The study tests Romosozumab's effects on bone formation and breakdown in women with both multiple myeloma and osteoporosis. It aims to determine the safety and effectiveness of this treatment for managing myeloma-related bone disease.

What are the potential side effects?

While not explicitly stated here, common side effects from similar medications may include joint pain, headache, nausea, injection site reactions; rare but serious risks could involve heart problems or jawbone issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tests show a high number of plasma cells in my bone marrow or a confirmed plasmacytoma.

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My myeloma is causing damage to my organs.

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I've had 4 or fewer IV bisphosphonate doses in the last year, with the last dose over 3 months ago.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had dental or oral surgery that hasn't fully healed.

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I have had a heart attack or stroke in the last year.

Select...

I am currently on medication to prevent bone loss.

Select...

I was assigned male at birth.

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I have had osteonecrosis of the jaw.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence and severity of adverse events

Side effects data

From 2016 Phase 3 trial • 245 Patients • NCT02186171

21%

Nasopharyngitis

Back pain

Hypertension

Constipation

Arthralgia

Headache

Procedural pain

Muscle spasms

Myalgia

Depression

Appendicitis perforated

Pneumonia

Implant site haematoma

Thoracic vertebral fracture

Death

Cerebral ischaemia

Depressed mood

Atrial flutter

Appendicitis

Osteoarthritis

Vascular encephalopathy

Urinary tract infection

Carotid artery stenosis

Anaemia postoperative

Haemorrhagic stroke

Cholecystitis

Non-cardiac chest pain

Benign prostatic hyperplasia

Angina unstable

Cardio-respiratory arrest

Basal cell carcinoma

Coronary artery stenosis

Wolff-Parkinson-White syndrome

Cerebrovascular accident

Escherichia sepsis

Subdural haematoma

Oropharyngeal cancer

Device related infection

Myocardial ischaemia

Gastrooesophageal reflux disease

Carotid arteriosclerosis

Cardiac failure

Laceration

Rib fracture

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Romosozumab 210 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RomosozumabExperimental Treatment1 Intervention

Romosozumab will be given on-label for osteoporosis at 210 mg administered SC once monthly for 12 months in conjunction with antimyeloma therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romosozumab

2021

Completed Phase 4

~13930

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Myeloma (MM) often target bone health due to the disease's impact on bone density. Romosozumab, a monoclonal antibody, inhibits sclerostin to promote bone formation and decrease bone resorption, which is vital for managing bone density and reducing skeletal-related events (SREs) in MM patients. Other treatments like bisphosphonates and denosumab work by inhibiting osteoclast-mediated bone resorption, thereby reducing bone pain and the risk of fractures. These mechanisms are crucial for maintaining bone integrity and improving the quality of life for MM patients.

Monoclonal antibodies against RANKL and sclerostin for myeloma-related bone disease: can they change the standard of care?