A Pilot Study of Romosozumab Efficacy and Safety for the Management of Myeloma-related OsteoLytic Disease in Postmenopausal Women With Multiple Myeloma and Osteoporosis (REMOLD-MM) REMOLD-MM

What's the purpose of this trial?

The purpose of this study is to measure the effect of romosozumab on bone formation and breakdown (resorption) and determine if romosozumab is a safe treatment for osteoporosis and myeloma-related bone disease (MBD) in postmenopausal people with multiple myeloma (MM).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Documented MM per International Myeloma Working Group diagnostic criteria (evidence of myeloma defining event attributed to underlying plasma cell disorder): i. Clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma; and ii. Any one or more of the following myeloma defining events:
* Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder:

1. Hypercalcemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL)
2. Renal insufficiency: creatinine clearance \< 40 mL/min or serum creatinine 177µmol/L (\>2 mg/dL)
3. Anemia: hemoglobin \> 2 g/dL below the lower limit of normal, or a hemoglobin value \<10 g/dL
4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET/CT
* Clonal bone marrow plasma cell percentage ≥ 60%; or
* Involved: uninvolved serum free light chain (FLC) ratio ≥ 100 (involved FLC level be ≥ 10 mg/dL; or
* \>1 focal lesion on MRI studies (at least 5 mm in size)
* Presence of lytic bone lesion(s) due to MM based on radiographic evidence with at least one measurable lesion (≥0.5 cm in its largest diameter by computerized tomography \[CT\])
* Postmenopausal female, defined as last menstrual cycle at least 12 months prior to study enrollment
* Must have one of the following:

* osteoporosis on dual X-ray absorptiometry (DXA) scan; or
* fragility fracture of the spine or hip; or
* morphometric spine fracture; or
* osteopenia with elevated risk of fracture (calculated by the FRAX online calculator)
* Within 12 months prior to study entry, ≤ 4 doses of prior intravenous bisphosphonate with the last dose ≥ 3 months prior to study entry.
* Prior oral bisphosphonates are allowed if the last dose was ≥ 3 months prior to study entry.
* Signed informed consent form(s). Individuals with impaired decision-making capacity may enroll if legally authorized representatives consent on behalf of individuals with impaired decision-making capacity.
* Ability to comply with all study-related procedures in the investigator's judgment
* 18 years of age or older

Exclusion Criteria:

* Assigned male at birth
* Received denosumab within 12 months prior to study entry
* Received teriparatide or other PTH analog use within 12 months prior to study entry
* Receiving concurrent antiresorptive therapy
* History of cardiovascular event (myocardial infarction and/or stroke) within the past 12 months of study entry
* History of non-healed dental or oral surgery
* History of osteonecrosis of the jaw
* 25 (OH) vitamin D levels \< 20 ng/mL. Vitamin D repletion will be permitted and subjects may be rescreened once 25 (OH) vitamin D level ≥ 20 ng/mL.
* Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (\<8.5 or \>10.5 mg/dL).

Additional Trial Information

Phase 1

Enrollment: 10 patients (estimated)

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Trial Locations

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New Jersey

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

Commack, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

West Harrison, NY

Open and Accepting
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