Multiple MyelomaNCT06457464
Clinical Outcomes and Prognostic Factors in Multiple Myeloma Patients
An observational study of Multiple Myeloma, run by Assiut University.
Trial summary
1. Description of the demographic, clinical, and laboratory characteristics of patients with MM admitted to the hematology unit of Assuit University Hospitals. 2. Determination of treatment outcomes and prognostic factors associated with survival rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Chemotherapy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Sample size was calculated using Epi- Info7. According to results of previous study. Based on this percentage, confidence limits of 5% and a confidence level of 90%, the sample needed for the study was estimated to be about 97 patients.
Who may be able to join
- Patients ≥ 18 years old diagnostic as MM with Eastern Cooperative Oncology Group performance status(ECOG) Performance Status (0-2)
Who cannot join
- Patients with poor performing status unfit to receive chemotherapy with ECOG PS > 2
About this study
Official title: Clinical Outcomes and Prognostic Factors in Patients With Multiple Myeloma in Assuit University Hospitals ( Prospective and Retrospective Study)
- Description of the demographic, clinical, and laboratory characteristics of patients with MM admitted to the hematology unit of Assuit University Hospitals.
- Determination of treatment outcomes and prognostic factors associated with survival rates.
Read the detailed description
Multiple Myeloma MM (plasma cell myeloma) represents a malignant proliferation of plasma cells derived from B cells. Its median age of diagnosis is 52-61 years but is less common under 40 years. Males are affected more than females.
Diagnostic criteria for Multiple Myeloma:
- Clonal bone marrow plasma cells or biopsy-proven bony or extramedullary plasmacytoma and any one of the following myeloma-defining events.
- Evidence of one or more end-organ damage that can be attributed to the underlying plasma cell proliferative disorder specifically:
- Hypercalcemia: serum calcium > 0.25mmol/l(>1 mg /dl) higher than the upper limit of normal or > 2.75mmol/l (>11mg/dl).
- Renal insufficiency: creatinine clearance <40 ml per min or serum creatinine >177 µmol (>2 mg/dl) .
- Anaemia : (hemoglobin value of < 10g/dl or hemoglobin > 2g/dl below the lower limit of normal
- Bone lesions: one or more osteolytic lesions on skeletal radiography, CT or PET CT ∙ Any one or more of the following biomarkers of malignancy:
- Clonal bone marrow plasma cells percentage > 60 %.
- Involved: uninvolved serum-free light chain ratio ≥100.
- >1 focal lesion on MRI studies. It causes many organ dysfunctions and symptoms such as renal failure, bony pains or fractures, anemia, susceptibility to infection, hypercalcemia, neurologic symptoms, and manifestation of hyperviscosity. It is characterized by the development of osteolytic lesions in the bone and involves the activation of osteoclasts with simultaneous suppression of new bone formation of osteoblast inhibition Bone pain is the most common symptom. Other presentations are anemia, hypercalcemia, renal failure, weight loss. Rare features are cord compression and CNS involvement.
The MM stage at presentation was documented according to the International Staging System (ISS) scoring and Durie-Salmon.
Over the last few decades, the management of MM has included chemotherapy: combination regimens including VCD (Velcade, cyclophosphamide, and dexamethasone ) or (MP) combination (melphalan and prednisolone) or VRD (Velcade, lenalidomide, dexamethasone) or VDT (Velcade, thalidomide, dexamethasone) or CRD (Cyclophosphamide, lenalidomide, dexamethasone ) or CDT (Cyclophosphamide, thalidomide, dexamethasone).
Then Follow-up will be for the patients after receiving their treatment for at least 18 months regarding response and survival analysis. and the novel therapies have significantly improved outcomes Autologous stem cell transplantation (ASCT) is an essential treatment strategy in the management of MM in young and fit patients.
In this study, we will present data of MM patients at the hematology unit in Assuit University hospitals from the year {2015:2025} including the demographic details, clinical presentations, laboratory features, treatment provided, response, and outcomes. We intended to explore the current situation of MM management, including the variety of drugs used and their responses, and patients undergoing ASCT and its outcome.
- Conditions
- Multiple Myeloma
- Being tested
- Chemotherapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
combination regimens including VCD (Velcade, cyclophosphamide, and dexamethasone ) or (MP) combination (melphalan and prednisolone) or VRD (Velcade, lenalidomide, dexamethasone) or VDT (Velcade, thalidomide, dexamethasone) or CRD (Cyclophosphamide, lenalidomide, dexamethasone ) or CDT (Cyclophosphamide, thalidomide, dexamethasone)
What is being measured
The primary outcome is the main question the study is designed to answer.
variety of drugs used and their responses, and pateints
examine the current state of multiple myeloma management, including the variety of drugs used and their effectiveness, as well as the outcomes for patients undergoing autologous stem cell transplantation (ASCT).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hassan Hassan Bakr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457464
- Sponsor's protocol ID
- COPFPMM
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kyle RA, Gertz MA, Witzig TE, Lust JA, Lacy MQ, Dispenzieri A, Fonseca R, Rajkumar SV, Offord JR, Larson DR, Plevak ME, Therneau TM, Greipp PR. Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc. 2003 Jan;78(1):21-33. doi: 10.4065/78.1.21.
PubMed 12528874Shin J, Koh Y, Youk J, Kim M, Kim BS, Choi CW, Sung HJ, Park Y, Yoon SS, Kim I. Clinicopathological characteristics of extremely young Korean multiple myeloma patients: therapeutic implications. Korean J Intern Med. 2017 Jul;32(4):722-730. doi: 10.3904/kjim.2016.256. Epub 2017 Jun 26.
PubMed 28651310Greipp PR, San Miguel J, Durie BG, Crowley JJ, Barlogie B, Blade J, Boccadoro M, Child JA, Avet-Loiseau H, Kyle RA, Lahuerta JJ, Ludwig H, Morgan G, Powles R, Shimizu K, Shustik C, Sonneveld P, Tosi P, Turesson I, Westin J. International staging system for multiple myeloma. J Clin Oncol. 2005 May 20;23(15):3412-20. doi: 10.1200/JCO.2005.04.242. Epub 2005 Apr 4.
PubMed 15809451Richardson PG, Hideshima T, Anderson KC. Bortezomib (PS-341): a novel, first-in-class proteasome inhibitor for the treatment of multiple myeloma and other cancers. Cancer Control. 2003 Sep-Oct;10(5):361-9. doi: 10.1177/107327480301000502.
PubMed 14581890
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Prognostic Factors in Patients With Multiple Myeloma in Assuit University Hospitals ( Prospective and Retrospective Study)
- ClinicalTrials.gov ID
- NCT06457464
- Acronym / sponsor ID
- COPFPMM
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Description of the demographic, clinical, and laboratory characteristics of patients with MM admitted to the hematology unit of Assuit University Hospitals.
- Determination of treatment outcomes and prognostic factors associated with survival rates.
Detailed description
Multiple Myeloma MM (plasma cell myeloma) represents a malignant proliferation of plasma cells derived from B cells. Its median age of diagnosis is 52-61 years but is less common under 40 years. Males are affected more than females.
Diagnostic criteria for Multiple Myeloma:
- Clonal bone marrow plasma cells or biopsy-proven bony or extramedullary plasmacytoma and any one of the following myeloma-defining events.
- Evidence of one or more end-organ damage that can be attributed to the underlying plasma cell proliferative disorder specifically:
- Hypercalcemia: serum calcium > 0.25mmol/l(>1 mg /dl) higher than the upper limit of normal or > 2.75mmol/l (>11mg/dl).
- Renal insufficiency: creatinine clearance <40 ml per min or serum creatinine >177 µmol (>2 mg/dl) .
- Anaemia : (hemoglobin value of < 10g/dl or hemoglobin > 2g/dl below the lower limit of normal
- Bone lesions: one or more osteolytic lesions on skeletal radiography, CT or PET CT ∙ Any one or more of the following biomarkers of malignancy:
- Clonal bone marrow plasma cells percentage > 60 %.
- Involved: uninvolved serum-free light chain ratio ≥100.
- >1 focal lesion on MRI studies. It causes many organ dysfunctions and symptoms such as renal failure, bony pains or fractures, anemia, susceptibility to infection, hypercalcemia, neurologic symptoms, and manifestation of hyperviscosity. It is characterized by the development of osteolytic lesions in the bone and involves the activation of osteoclasts with simultaneous suppression of new bone formation of osteoblast inhibition Bone pain is the most common symptom. Other presentations are anemia, hypercalcemia, renal failure, weight loss. Rare features are cord compression and CNS involvement.
The MM stage at presentation was documented according to the International Staging System (ISS) scoring and Durie-Salmon.
Over the last few decades, the management of MM has included chemotherapy: combination regimens including VCD (Velcade, cyclophosphamide, and dexamethasone ) or (MP) combination (melphalan and prednisolone) or VRD (Velcade, lenalidomide, dexamethasone) or VDT (Velcade, thalidomide, dexamethasone) or CRD (Cyclophosphamide, lenalidomide, dexamethasone ) or CDT (Cyclophosphamide, thalidomide, dexamethasone).
Then Follow-up will be for the patients after receiving their treatment for at least 18 months regarding response and survival analysis. and the novel therapies have significantly improved outcomes Autologous stem cell transplantation (ASCT) is an essential treatment strategy in the management of MM in young and fit patients.
In this study, we will present data of MM patients at the hematology unit in Assuit University hospitals from the year {2015:2025} including the demographic details, clinical presentations, laboratory features, treatment provided, response, and outcomes. We intended to explore the current situation of MM management, including the variety of drugs used and their responses, and patients undergoing ASCT and its outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Sample size was calculated using Epi- Info7. According to results of previous study. Based on this percentage, confidence limits of 5% and a confidence level of 90%, the sample needed for the study was estimated to be about 97 patients.
Key inclusion criteria (1 listed)
- Patients ≥ 18 years old diagnostic as MM with Eastern Cooperative Oncology Group performance status(ECOG) Performance Status (0-2)
Key exclusion criteria (1 listed)
- Patients with poor performing status unfit to receive chemotherapy with ECOG PS > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapycombination regimens including VCD (Velcade, cyclophosphamide, and dexamethasone ) or (MP) combination (melphalan and prednisolone) or VRD (Velcade, lenalidomide, dexamethasone) or VDT (Velcade, thalidomide, dexamethasone) or CRD (Cyclophosphamide, lenalidomide, dexamethasone ) or CDT (Cyclophosphamide, thalidomide, dexamethasone) | Drug | – |
Primary outcome
variety of drugs used and their responses, and pateints
Time frame: baseline
examine the current state of multiple myeloma management, including the variety of drugs used and their effectiveness, as well as the outcomes for patients undergoing autologous stem cell transplantation (ASCT).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 12528874Kyle RA, Gertz MA, Witzig TE, Lust JA, Lacy MQ, Dispenzieri A, Fonseca R, Rajkumar SV, Offord JR, Larson DR, Plevak ME, Therneau TM, Greipp PR. Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc. 2003 Jan;78(1):21-33. doi: 10.4065/78.1.21.
- Background: PubMed 28651310Shin J, Koh Y, Youk J, Kim M, Kim BS, Choi CW, Sung HJ, Park Y, Yoon SS, Kim I. Clinicopathological characteristics of extremely young Korean multiple myeloma patients: therapeutic implications. Korean J Intern Med. 2017 Jul;32(4):722-730. doi: 10.3904/kjim.2016.256. Epub 2017 Jun 26.
- Background: PubMed 15809451Greipp PR, San Miguel J, Durie BG, Crowley JJ, Barlogie B, Blade J, Boccadoro M, Child JA, Avet-Loiseau H, Kyle RA, Lahuerta JJ, Ludwig H, Morgan G, Powles R, Shimizu K, Shustik C, Sonneveld P, Tosi P, Turesson I, Westin J. International staging system for multiple myeloma. J Clin Oncol. 2005 May 20;23(15):3412-20. doi: 10.1200/JCO.2005.04.242. Epub 2005 Apr 4.
- Background: PubMed 14581890Richardson PG, Hideshima T, Anderson KC. Bortezomib (PS-341): a novel, first-in-class proteasome inhibitor for the treatment of multiple myeloma and other cancers. Cancer Control. 2003 Sep-Oct;10(5):361-9. doi: 10.1177/107327480301000502.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variety of drugs used and their responses, and pateints (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06457464, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.