A Phase 1/2 interventional study of Lenalidomide plus Melphalan during autologous stem cell transplantation and Lenalidomide maintenance in Multiple Myeloma, sponsored by Attaya Suvannasankha. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Attaya Suvannasankha · Phase 1/2, Interventional, and Treatment
This is a research study for newly diagnosed multiple myeloma or multiple myeloma has returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells called plasma cells. Plasma cells make proteins that help fight infections. Current therapy for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells) stem cell transplantation.
There will be two parts (or phases) to this study:
The purpose of the first part is to find the highest dose of a drug called lenalidomide (Revlimid®) that can be given in combination with high dose melphalan without causing severe adverse events.
The purpose of the second part is to find out the effects of this treatment (good and bad) on multiple myeloma patients.
Lenalidomide is a drug that interferes with the development of tiny blood vessels that help tumors grow. Lenalidomide in combination with dexamethasone is approved by the Food and Drug Administration (FDA) for the treatment of relapsed multiple myeloma. It is also approved for the treatment of specific types of myelodysplastic syndrome (MDS), another blood cancer. Other research studies using lenalidomide in combination with other drugs in subjects with newly diagnosed multiple myeloma also show good response rate.
High dose melphalan is approved by the FDA and is commonly used in multiple myeloma treatment prior to stem cell transplantation. This combination of lenalidomide, high-dose melphalan and stem cell transplantation has not been studied in newly diagnosed and relapsed multiple myeloma, so it is considered experimental. In research studies, "experimental" refers to a drug or procedure that has undergone basic laboratory testing and received approval from the US Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered experimental in other diseases or conditions.
In this study, lenalidomide will be given together with melphalan (chemotherapy) with the hope that more disease will be killed before the stem cell transplant. Three months after the transplant, patients will take lenalidomide again with the hope that this will help prolong the time when the disease is in remission.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 60 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Attaya Suvannasankha is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Melphalan will be given on Day -2 and Day -1. Lenalidomide will be given from Day -7 to Day +2.
Drug: Lenalidomide plus Melphalan during autologous stem cell transplantation · Drug: Lenalidomide maintenance
Patients will receive a fixed dose of melphalan, while the dose of lenalidomide is escalated according to the protocol defined cohorts. Lenalidomide is given on day -7 to day +2, while intravenous melphalan is given on day -2 and -1. Lenalidomide dosing will be in the morning at approximately the same time each day.
Lenalidomide maintenance therapy will begin on Day +100 to Day +110 provided the protocol-defined criteria are met. The initial starting dose of lenalidomide during maintenance is 10 mg daily on Days 1-28 of each 28-day cycle.
Phase I: Number of Patients With Dose Limiting Toxicity
The number of patients who had a DLT during the dose finding portion (Phase I) of the trial for the safety of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma.
Time frame: up to 1 month
Phase II: Overall Response Rate
Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better (CR+sCR+VGPR+PR). The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for Multiple Myeloma (CR= Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow; sCR=CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunoflurorescence; VGPR=Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component\<100 mg per 24 h; PR=\>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200mg per 24 h).
Time frame: up to 5 years
Phase II: Treatment-Related Adverse Events Grade 3 or Higher
Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.
Time frame: up to 5 years
This protocol was based on enrolling up to 16 patients phase I and up to 46 patients in phase II. The study enrolled 60 patients with 16 in phase I and 44 in phase II.
| Milestone | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 | Phase II |
|---|---|---|---|---|---|
| Started | 3 | 4 | 3 | 6 | 44 |
| Completed | 0 | 0 | 0 | 1 | 10 |
| Not completed | 3 | 4 | 3 | 5 | 34 |
| Withdrew: Adverse event | 1 | 2 | 1 | 0 | 4 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Disease progression | 2 | 0 | 1 | 2 | 12 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 3 |
| Withdrew: Physician decision | 0 | 1 | 0 | 2 | 10 |
| Withdrew: Alternative therapy | 0 | 1 | 1 | 0 | 1 |
| Withdrew: Off trt for other complicating disease | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Noncompliance | 0 | 0 | 0 | 0 | 2 |
The number of patients who had a DLT during the dose finding portion (Phase I) of the trial for the safety of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma.
| Participants | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 |
|---|---|---|---|---|
| Phase I: Number of Patients With Dose Limiting Toxicity | 0 | 0 | 0 | 0 |
Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better (CR+sCR+VGPR+PR). The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for Multiple Myeloma (CR= Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow; sCR=CR as defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunoflurorescence; VGPR=Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component\<100 mg per 24 h; PR=\>=50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \>=90% or to \<200mg per 24 h).
| percentage of participants | Phase II |
|---|---|
| Phase II: Overall Response Rate | 87.5 (73.2 to 95.8) |
Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.
| Participants | Phase II |
|---|---|
| Phase II: Treatment-Related Adverse Events Grade 3 or Higher | 18 |
Collected over up to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I, Dose Level 1 | — | 0/3 (0%) | 3/3 (100%) |
| Phase I, Dose Level 2 | — | 1/4 (25%) | 4/4 (100%) |
| Phase I, Dose Level 3 | — | 2/3 (66.7%) | 3/3 (100%) |
| Phase I, Dose Level 4 | — | 3/6 (50%) | 6/6 (100%) |
| Phase II | — | 11/44 (25%) | 44/44 (100%) |
| Event | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 | Phase II |
|---|---|---|---|---|---|
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/3 | 1/4 | 2/3 | 1/6 | 0/44 |
| FeverGeneral disorders | 0/3 | 0/4 | 1/3 | 1/6 | 0/44 |
| SepsisInfections and infestations | 0/3 | 0/4 | 1/3 | 1/6 | 1/44 |
| Bronchopulmonary hemorrhageRespiratory, thoracic and mediastinal disorders | 0/3 | 0/4 | 1/3 | 0/6 | 0/44 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/3 | 0/4 | 1/3 | 0/6 | 0/44 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/3 | 0/4 | 1/3 | 0/6 | 0/44 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/3 | 0/4 | 1/3 | 0/6 | 0/44 |
| Infections and infestations - OtherInfections and infestations | 0/3 | 1/4 | 0/3 | 1/6 | 1/44 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 0/3 | 1/4 | 0/3 | 0/6 | 0/44 |
| PainGeneral disorders | 0/3 | 0/4 | 0/3 | 1/6 | 0/44 |
| Event | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 | Phase II |
|---|---|---|---|---|---|
| DiarrheaGastrointestinal disorders | 3/3 | 2/4 | 3/3 | 6/6 | 39/44 |
| NauseaGastrointestinal disorders | 2/3 | 2/4 | 3/3 | 6/6 | 39/44 |
| Edema limbsGeneral disorders | 0/3 | 1/4 | 3/3 | 4/6 | 14/44 |
| FatigueGeneral disorders | 3/3 | 3/4 | 3/3 | 6/6 | 32/44 |
| HypocalcemiaMetabolism and nutrition disorders | 3/3 | 2/4 | 0/3 | 0/6 | 0/44 |
| Back painMusculoskeletal and connective tissue disorders | 3/3 | 2/4 | 1/3 | 3/6 | 16/44 |
| HypotensionVascular disorders | 0/3 | 1/4 | 3/3 | 0/6 | 5/44 |
| Peripheral sensory neuropathyNervous system disorders | 2/3 | 2/4 | 2/3 | 5/6 | 16/44 |
| PainGeneral disorders | 0/3 | 3/4 | 1/3 | 3/6 | 20/44 |
| Infections and infestations - OtherInfections and infestations | 0/3 | 3/4 | 1/3 | 3/6 | 8/44 |
| Age, Categorical(Participants) | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 | Phase II | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 | 5 | 34 | 45 |
| >=65 years | 1 | 3 | 0 | 1 | 10 | 15 |
| Age, Continuous(years) | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 | Phase II | Total |
|---|---|---|---|---|---|---|
| Mean | 62.3 ± 7.3 | 63.0 ± 11.7 | 56.1 ± 10.8 | 56.6 ± 9.1 | 58.6 ± 8.4 | 58.7 ± 8.6 |
| Sex: Female, Male(Participants) | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 | Phase II | Total |
|---|---|---|---|---|---|---|
| Female | 1 | 0 | 1 | 1 | 13 | 16 |
| Male | 2 | 4 | 2 | 5 | 31 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 | Phase II | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 4 | 3 | 6 | 43 | 59 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Phase I, Dose Level 1 | Phase I, Dose Level 2 | Phase I, Dose Level 3 | Phase I, Dose Level 4 | Phase II | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 4 | 5 |
| White | 3 | 4 | 3 | 5 | 38 | 53 |
| More than one race | 0 | 0 | 0 | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Attaya Suvannasankha