Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Treatment | Experimental | Isatuximab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isatuximab | Drug | Subcutaneous isatuximab will be administered weekly on a 28-day cycle during the first two cycles, and every two weeks of a 28-day cycle thereafter. Dexamethasone will be administered on the days of isatuximab administration and can be discontinued after two cycles of therapy, or continued at discretion of investigator. Lenalidomide, will be added after two cycles of therapy have been completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of 9 cycles of treatment | Assess the feasibility of approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of lenalidomide from the third cycle onwards in ultra-frail patients with myeloma | At the end of 9 cycles of treatment (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life as per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 domain | Assess if an approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of a lenalidomide in ultra-frail patients with myeloma leads to an improvement in quality of life as measured by the EORTC score. The questionnaire has 10 subscales, each with a score range of 0 to 100 points. Higher scores on the functional scales and global quality of life indicate better functioning, while higher scores on the symptom scales indicate a higher symptom burden. The QLQ-C30 summary score is calculated by averaging the scores of the 13 scales and items, with a higher score indicating a better health-related quality of life (HRQoL). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Kingsford | Contact | 801-585-0115 | rachel.kingsford@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ghulam Rehman Mohyuddin, MBBS | Huntsman Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute at the University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D007952 | Leukemia, Plasma Cell |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599209 | isatuximab |
| D003907 | Dexamethasone |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
This is a single arm phase 2 study.
Not provided
Not provided
Not provided
Not provided
|
|
| At the end of 4 cycles of treatment (each cycle is 28 days) |
| Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. | At study completion. Participants will be enrolled in study for about 3 years. |
| Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0) | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. | At study completion. Participants will be enrolled in study for about 3 years. |
| Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. | At study completion. Participants will be enrolled in study for about 3 years. |
| Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. | At study completion. Participants will be enrolled in study for about 3 years. |
| Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. | At study completion. Participants will be enrolled in study for about 3 years. |
| Overall survival (OS) | Assess overall survival in this study population | Time from registration until 3 years from start of therapy or death from any cause. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007938 | Leukemia |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |