Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely added to high-dose melphalan prior to autologous stem cell transplantation (ASCT).
B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by maintenance standard-dose lenalidomide improves the response rate and duration of response for relapsed multiple myeloma (RMM).
Experimental: Phase 1 Subjects will dose escalate lenalidomide in a series of subjects in a 3+3 design through 6 dose levels of lenalidomide (as per modified Fibonacci escalation) to determine the maximal tolerated dose (MTD)of lenalidomide prior to ASCT.
Planned dose levels of lenalidomide in Phase 1 portion of study:
Dose Level/ Lenalidomide Dose / Schedule
-1: 25mg daily x 5 days
Experimental: Phase 2 The MTD determine for lenalidomide in the phase 1 portion of this study will be used in the transplant phase of the phase 2 portion.
In the transplant phase of the study, all participants will receive oral lenalidomide at the pre-determined dose level for phase 1 and MTD for phase 2 for 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.
Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose level 1 | Experimental | Oral lenalidomide 25mg twice daily x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). |
|
| Phase 1 Dose level 2 | Experimental | Oral lenalidomide 25mg qAM, 50mq qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). |
|
| Phase 1 Dose level 3 | Experimental | Oral lenalidomide 50mg qAM, 75mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide | Drug | daily dose dependent on dose-escalation schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Lenalidomide That Can be Added to Melphalan | The primary endpoint for the phase 1 portion of this study is to determine the maximum tolerated dose of lenalidomide that can be added to melphalan. | 12 months |
| Duration of Overall Response (DoR) | The primary endpoint for the phase 2 portion of this study is to determine the duration of overall response (DoR). The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). | Until disease progression, death, or for a maximum of 3 years, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response rate is the number of patients with complete response and partial response. Response is defined by the International Uniform Response Criteria for Multiple Myeloma (IURC) | Until disease progression or a maximum of 3 years, whichever occurs first |
| Overall Survival |
Not provided
Inclusion Criteria:
Patients must have histologically or cytologically confirmed relapsed, primary refractory, or relapsed and refractory multiple myeloma.
Patients must have measurable disease as defined by the International Uniform Response Criteria,defined as any of the following:
Patients must have received at least one prior line of therapy.
Age > = 18 years.
Life expectancy of greater than 12 weeks.
ECOG performance status < = 2.
All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist.
Patients must have normal organ and marrow function as defined below:
Patients must have an adequate number of CD34+ stem cells collected to allow for transplantation. This number is defined as ≥ 2 x 106 CD34+ cells / kg body weight. If not previously collected and stored, the patient must be willing to undergo stem cell mobilization and collection as per standard practice.
The effects of lenalidomide on the developing human fetus at the recommended therapeutic dose are unknown; however, it has been shown to be teratogenic other primates. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. The treating physician will follow the adverse reporting guidelines as outlined in further detail below for pregnancies.
Lenalidomide has been shown to carry a risk of thromboembolic events, especially when used in combination with either corticosteroids or alkylating chemotherapeutic agents. All patients who participate in this study must be willing and able to tolerate prophylactic anticoagulation with low-molecular weight heparin (LMWH) for the required dates in treatment protocol. Patients also must be able to tolerate low-dose aspirin, 81 mg daily, during the maintenance phase of the treatment protocol.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roger Pearse, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 Dose Level 1 | Oral lenalidomide 25mg twice daily x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Phase 1 Dose level 4 | Experimental | Oral lenalidomide 75mg qAM, 100mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). |
|
| Phase 1 Dose level 5 | Experimental | Oral lenalidomide 100mg qAM, 150mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). |
|
| Phase 1 Dose level 6 | Experimental | Oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). |
|
| Phase 2 Expansion | Experimental | Early studies noted a dose response relationship and found myelosuppression to be the dose limiting toxicity. In this Phase 1 study of high dose lenalidomide (HDLEN) with HDM in conditioning for ASCT shown no DLT noted up to 350mg PO daily of LEN. In Phase 2, HDLEN was dosed at 350mg PO daily from day -5 to day -1 and HDM was dosed 100mg/m2 on days -2 and -1. After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
|
|
| melphalan | Drug | 100 mg/m2 given Days -2 and -1 |
|
Overall survival is defined as the interval between the day of transplantation (Day 0) and date of death. If the date of death is uncertain, the date of last contact with the subject will be used. |
| Until death or date of last contact with the subject |
| Mean Functional Assessment of of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Score | quality of life will be evaluated and scored using the questionnaire from the bone marrow transplant subscale of the Functional Assessment of Cancer Therapy available from w ww.facit.org. The FACT-BMT is a 50 item questionnaire that measures five dimensions of quality of life in bone marrow transplant patients, including physical well-being, social and family well-being, emotional well-being, functional well-being, and additional concerns. It is scored on a 5 point Likert scale. Total scores range from 0 to 148, with a higher score indicating higher quality of life. | Cycle 6, day 1, at approximately 4.5 months |
| FG001 | Phase 1 Dose Level 2 | Oral lenalidomide 25mg qAM, 50mq qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| FG002 | Phase 1 Dose Level 3 | Oral lenalidomide 50mg qAM, 75mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| FG003 | Phase 1 Dose Level 4 | Oral lenalidomide 75mg qAM, 100mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| FG004 | Phase 1 Dose Level 5 | Oral lenalidomide 100mg qAM, 150mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| FG005 | Phase 1 Dose Level 6 | Oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| FG006 | Phase 2 Expansion | Early studies noted a dose response relationship and found myelosuppression to be the dose limiting toxicity. In this Phase 1 study of high dose lenalidomide (HDLEN) with HDM in conditioning for ASCT shown no DLT noted up to 350mg PO daily of LEN. In Phase 2, HDLEN was dosed at 350mg PO daily from day -5 to day -1 and HDM was dosed 100mg/m2 on days -2 and -1. After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 Dose Level 1 | Oral lenalidomide 25mg twice daily x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| BG001 | Phase 1 Dose Level 2 | Oral lenalidomide 25mg qAM, 50mq qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| BG002 | Phase 1 Dose Level 3 | Oral lenalidomide 50mg qAM, 75mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| BG003 | Phase 1 Dose Level 4 | Oral lenalidomide 75mg qAM, 100mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| BG004 | Phase 1 Dose Level 5 | Oral lenalidomide 100mg qAM, 150mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| BG005 | Phase 1 Dose Level 6 | Oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| BG006 | Phase 2 MTD | Phase 2 MTD, oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Immunoglobulin Isotype | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Lenalidomide That Can be Added to Melphalan | The primary endpoint for the phase 1 portion of this study is to determine the maximum tolerated dose of lenalidomide that can be added to melphalan. | This outcome measure only assesses Phase 1 participants | Posted | Number | mg/day | 12 months |
|
|
| ||||||||||||||||||||||||||
| Primary | Duration of Overall Response (DoR) | The primary endpoint for the phase 2 portion of this study is to determine the duration of overall response (DoR). The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). | This outcome measure only assesses Phase 2 participants | Posted | Number | participants | Until disease progression, death, or for a maximum of 3 years, whichever occurs first |
| ||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | Overall response rate is the number of patients with complete response and partial response. Response is defined by the International Uniform Response Criteria for Multiple Myeloma (IURC) | Not Posted | Until disease progression or a maximum of 3 years, whichever occurs first | Participants | |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the interval between the day of transplantation (Day 0) and date of death. If the date of death is uncertain, the date of last contact with the subject will be used. | Not Posted | Until death or date of last contact with the subject | Participants | |||||||||||||||||||||||||||||||
| Secondary | Mean Functional Assessment of of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Score | quality of life will be evaluated and scored using the questionnaire from the bone marrow transplant subscale of the Functional Assessment of Cancer Therapy available from w ww.facit.org. The FACT-BMT is a 50 item questionnaire that measures five dimensions of quality of life in bone marrow transplant patients, including physical well-being, social and family well-being, emotional well-being, functional well-being, and additional concerns. It is scored on a 5 point Likert scale. Total scores range from 0 to 148, with a higher score indicating higher quality of life. | Subjects from whom data were not collected were excluded from analysis. | Posted | Mean | Full Range | score on a scale | Cycle 6, day 1, at approximately 4.5 months |
|
Adverse events presented were collected for an average of 3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 Dose Level 1 | Oral lenalidomide 25mg twice daily x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 | 0 | 2 | 1 | 2 | 1 | 2 |
| EG001 | Phase 1 Dose Level 2 | Oral lenalidomide 25mg qAM, 50mq qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 | 0 | 4 | 2 | 4 | 4 | 4 |
| EG002 | Phase 1 Dose Level 3 | Oral lenalidomide 50mg qAM, 75mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 | 0 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Phase 1 Dose Level 4 | Oral lenalidomide 75mg qAM, 100mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 | 0 | 4 | 2 | 4 | 3 | 4 |
| EG004 | Phase 1 Dose Level 5 | Oral lenalidomide 100mg qAM, 150mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 | 0 | 6 | 3 | 6 | 6 | 6 |
| EG005 | Phase 1 Dose Level 6 | Oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 | 0 | 3 | 1 | 3 | 3 | 3 |
| EG006 | Phase 2 MTD | Phase 2 MTD, oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 | 0 | 30 | 8 | 30 | 29 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Hip pain |
|
| Ataxia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Diverticulitis |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastroenteritis |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Umbilical abscess |
|
| Lung infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Myocardiac Infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Basal cell carcinoma, lip |
|
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distention | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Activated PTT prolonged | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Acute kidney Injury | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acute otitis media | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Leukopenia |
|
| Blood bilirubin increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | eGFR decreased |
|
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Concentration impairement | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CPK increase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine increase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE (3.0) | Systematic Assessment | Hordeolum |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flu-like symptoms | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Gait alteration | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastroesophageal reflux | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Odynophagia |
|
| Gastropharesis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gum infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperlipidemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infusion-Related Reaction | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| INR increase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Intracranial Hemorrhage | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphocyte count increase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nail infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Non-cardiac Chest Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheral neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Post nasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Nocturia |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Tachypnea |
|
| Rhinitis Infective | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Scalp pain | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Shingles | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Skin lesion |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment | Hernia repair |
|
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | CTCAE (3.0) | Systematic Assessment | Hyperviscosity |
|
| Vasovagal reaction | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Viremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | HHV6 Viremia |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Pearse, M.D. PhD | Weill Cornell Medicine | 646-962-6500 | rnp2001@med.cornell.edu |
| Jan 14, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| 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 |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| IgG Kappa |
|
| IgA Lambda |
|
| IgA Kappa |
|
| IgD Kappa |
|
| Kappa Free light Chain |
|
| Lambda Free light Chain |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
Oral lenalidomide 25mg qAM, 50mq qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| OG002 | Phase 1 Dose Level 3 | Oral lenalidomide 50mg qAM, 75mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| OG003 | Phase 1 Dose Level 4 | Oral lenalidomide 75mg qAM, 100mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| OG004 | Phase 1 Dose Level 5 | Oral lenalidomide 100mg qAM, 150mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| OG005 | Phase 1 Dose Level 6 | Oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1). On days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
| OG006 | Phase 2 Expansion | Early studies noted a dose response relationship and found myelosuppression to be the dose limiting toxicity. In this Phase 1 study of high dose lenalidomide (HDLEN) with HDM in conditioning for ASCT shown no DLT noted up to 350mg PO daily of LEN. In Phase 2, HDLEN was dosed at 350mg PO daily from day -5 to day -1 and HDM was dosed 100mg/m2 on days -2 and -1. After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells. Maintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles). lenalidomide: daily dose dependent on dose-escalation schedule melphalan: 100 mg/m2 given Days -2 and -1 |
|
|