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Monoclonal Antibodies
Romosozumab for Osteoporosis in Multiple Myeloma
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will measure if romosozumab is a safe and effective treatment for postmenopausal people with MM and osteoporosis/MBD.
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.Check my eligibility
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.See study design
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 belowSelect...
My tests show a high number of plasma cells in my bone marrow or a confirmed plasmacytoma.
Select...
My myeloma is causing damage to my organs.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent change in bone formation marker, P1NP
Secondary outcome measures
Incidence and severity of adverse events
Side effects data
From 2016 Phase 3 trial • 245 Patients • NCT0218617121%
Nasopharyngitis
9%
Back pain
9%
Hypertension
6%
Arthralgia
6%
Constipation
6%
Headache
5%
Procedural pain
2%
Myalgia
2%
Muscle spasms
1%
Oropharyngeal cancer
1%
Cerebral ischaemia
1%
Urinary tract infection
1%
Subdural haematoma
1%
Laceration
1%
Rib fracture
1%
Anaemia postoperative
1%
Carotid artery stenosis
1%
Vascular encephalopathy
1%
Depressed mood
1%
Thoracic vertebral fracture
1%
Atrial flutter
1%
Death
1%
Device related infection
1%
Escherichia sepsis
1%
Coronary artery stenosis
1%
Cardio-respiratory arrest
1%
Carotid arteriosclerosis
1%
Cerebrovascular accident
1%
Angina unstable
1%
Implant site haematoma
1%
Non-cardiac chest pain
1%
Appendicitis perforated
1%
Cardiac failure
1%
Cholecystitis
1%
Appendicitis
1%
Pneumonia
1%
Haemorrhagic stroke
1%
Depression
1%
Benign prostatic hyperplasia
1%
Myocardial ischaemia
1%
Wolff-Parkinson-White syndrome
1%
Gastrooesophageal reflux disease
1%
Osteoarthritis
1%
Basal cell carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Romosozumab 210 mg
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
~13910
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,879 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,157 Patients Enrolled for Multiple Myeloma
Carlyn Tan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a menstrual cycle in the last 12 months.I last took oral bisphosphonates more than 3 months ago.I have had dental or oral surgery that hasn't fully healed.My tests show a high number of plasma cells in my bone marrow or a confirmed plasmacytoma.I have osteoporosis, a spine or hip fracture, or a high risk of fracture.My myeloma is causing damage to my organs.I've had 4 or fewer IV bisphosphonate doses in the last year, with the last dose over 3 months ago.You have been diagnosed with multiple myeloma according to specific medical guidelines.My vitamin D levels are currently below 20 ng/mL.I have had a heart attack or stroke in the last year.I have used denosumab under certain conditions.I am currently on medication to prevent bone loss.I am 18 years old or older.I, or my legal representative, have signed the consent form.I was assigned male at birth.I have not used teriparatide or similar drugs in the last year.Your blood calcium levels are too high or too low, as determined by your doctor.I have had osteonecrosis of the jaw.
Research Study Groups:
This trial has the following groups:- Group 1: Romosozumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any Canadian facilities administering this trial?
"At present, 7 clinical trial sites are available for this study. These locations span from Middletown to Montvale and Commack and beyond; it is beneficial to choose the closest one in order to reduce travel-related complications if you decide to participate."
Answered by AI
Has the U.S. Food and Drug Administration authorized Romosozumab for clinical use?
"Our team at Power assigned Romosozumab a score of 1 due to the limited efficacy and safety data available, as this is currently only in Phase 1."
Answered by AI
What is the current enrolment capacity for this research initiative?
"Affirmative. The online information hosted on clinicaltrials.gov verifies that this medical research, which was first published on March 7th 2023, is presently recruiting subjects to participate in the experiment. At present, 10 patients need to be enrolled through 7 distinct sites."
Answered by AI
Are any participants currently being sought for this research endeavor?
"According to the clinicaltrials.gov webpage, this research project is actively recruiting participants. It was initiated on March 7th 2023 and has been refreshed since then."
Answered by AI
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