18 and older, any sex, with Multiple Myeloma or Plasma Cell Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of TherapyPrimary· First cycle of therapy (28 days)
Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:
* Grade 3 or higher neutropenia with fever ≥38.5 degrees C
* Grade 4 neutropenia ≥7 days
* Grade 4 or higher thrombocytopenia
* Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause
Group
Value
95% CI
Group A Lenalidomide 10 mg/Day
0
Group A Lenalidomide 15 mg/Day
0
Group A Lenalidomide 25 mg/Day
0
Group B Lenalidomide 15 mg/2 Days
0
Group B Lenalidomide 25 mg/2 Days
0
Group B Lenalidomide 15 mg/Day
0
Group B Lenalidomide 25 mg/Day
0
Group C Lenalidomide 15 mg 3x/Week
0
Group C Lenalidomide 10 mg/Day
0
Group C Lenalidomide 15 mg/Day
0
Group C Lenalidomide 25 mg/Day
0
Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]Primary· 56 months
Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, \<5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90%
Group
Value
95% CI
Group A CrCl 30-60 mL/Min
60.0
39.4 – 78.3
Group B CrCL<30 mL/Min, Not on Dialysis
60.0
30.4 – 85.0
Group C CrCL<30 mL/Min and on Dialysis
20.0
1.0 – 65.7
Overall Survival TimeSecondary· 56 months
Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.
Group
Value
95% CI
Group A=30-60 CrCl (mL/Min)
20.8
11.0 – 42.1
Group B=CrCL<30 mL/Min Not on Dialysis
20.0
10.4 – 34.2
Group C=CrCL<30 mL/Min and on Dialysis
NA
10.4 – NA
Duration of ResponseSecondary· 56 months
Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attribu
Group
Value
95% CI
Group A=30-60 CrCl (mL/Min)
21.8
14.4 – 34.8
Group B=CrCL<30 mL/Min Not on Dialysis
8.4
7.9 – 9.4
Group C=CrCL<30 mL/Min and on Dialysis
25.4
25.4 – 25.4
Worst Degree Treatment-Related Adverse Events Across All Event Types Per PatientSecondary· 56 months
The highest degree of any adverse event experienced by each patient, as assessed by NCI CTCAE Version 4, with an attribution of possibly, probably, or definitely related to treatment. Reportable adverse events included those occurring while on treatment or within 30 days of the end of treatment.
None
Group
Value
95% CI
Group A Lenalidomide 10 mg/Day
3
Group A Lenalidomide 15 mg/Day
1
Group A Lenalidomide 25 mg/Day
1
Group A Expansion Cohort
1
Group B Lenalidomide 15 mg/2 Days
1
Group B Lenalidomide 25 mg/2 Days
1
Group B Lenalidomide 15 mg/Day
0
Group B Lenalidomide 25 mg/Day
1
Group B Expansion Cohort
0
Group C Lenalidomide 15 mg 3x/Week
3
Group C Lenalidomide 10 mg/Day
0
Group C Lenalidomide 15 mg/Day
0
Grade 1
Group
Value
95% CI
Group A Lenalidomide 10 mg/Day
0
Group A Lenalidomide 15 mg/Day
0
Group A Lenalidomide 25 mg/Day
1
Group A Expansion Cohort
4
Group B Lenalidomide 15 mg/2 Days
0
Group B Lenalidomide 25 mg/2 Days
0
Group B Lenalidomide 15 mg/Day
1
Group B Lenalidomide 25 mg/Day
1
Group B Expansion Cohort
1
Group C Lenalidomide 15 mg 3x/Week
0
Group C Lenalidomide 10 mg/Day
1
Group C Lenalidomide 15 mg/Day
2
Grade 2
Group
Value
95% CI
Group A Lenalidomide 10 mg/Day
2
Group A Lenalidomide 15 mg/Day
0
Group A Lenalidomide 25 mg/Day
0
Group A Expansion Cohort
3
Group B Lenalidomide 15 mg/2 Days
0
Group B Lenalidomide 25 mg/2 Days
0
Group B Lenalidomide 15 mg/Day
1
Group B Lenalidomide 25 mg/Day
2
Group B Expansion Cohort
0
Group C Lenalidomide 15 mg 3x/Week
0
Group C Lenalidomide 10 mg/Day
0
Group C Lenalidomide 15 mg/Day
0
Grade 3
Group
Value
95% CI
Group A Lenalidomide 10 mg/Day
1
Group A Lenalidomide 15 mg/Day
1
Group A Lenalidomide 25 mg/Day
4
Group A Expansion Cohort
6
Group B Lenalidomide 15 mg/2 Days
1
Group B Lenalidomide 25 mg/2 Days
1
Group B Lenalidomide 15 mg/Day
1
Group B Lenalidomide 25 mg/Day
3
Group B Expansion Cohort
0
Group C Lenalidomide 15 mg 3x/Week
0
Group C Lenalidomide 10 mg/Day
1
Group C Lenalidomide 15 mg/Day
1
Grade 4
Group
Value
95% CI
Group A Lenalidomide 10 mg/Day
0
Group A Lenalidomide 15 mg/Day
1
Group A Lenalidomide 25 mg/Day
0
Group A Expansion Cohort
0
Group B Lenalidomide 15 mg/2 Days
1
Group B Lenalidomide 25 mg/2 Days
1
Group B Lenalidomide 15 mg/Day
0
Group B Lenalidomide 25 mg/Day
1
Group B Expansion Cohort
1
Group C Lenalidomide 15 mg 3x/Week
0
Group C Lenalidomide 10 mg/Day
0
Group C Lenalidomide 15 mg/Day
0
Grade 5
Group
Value
95% CI
Group A Lenalidomide 10 mg/Day
0
Group A Lenalidomide 15 mg/Day
0
Group A Lenalidomide 25 mg/Day
0
Group A Expansion Cohort
0
Group B Lenalidomide 15 mg/2 Days
0
Group B Lenalidomide 25 mg/2 Days
0
Group B Lenalidomide 15 mg/Day
0
Group B Lenalidomide 25 mg/Day
0
Group B Expansion Cohort
0
Group C Lenalidomide 15 mg 3x/Week
0
Group C Lenalidomide 10 mg/Day
1
Group C Lenalidomide 15 mg/Day
0
Progression-free SurvivalSecondary· 56 months
Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment.
Group
Value
95% CI
Group A=30-60 CrCl (mL/Min)
12.6
6.5 – 25.1
Group B=CrCL<30 mL/Min Not on Dialysis
11.4
10.4 – 14.5
Group C=CrCL<30 mL/Min and on Dialysis
NA
2.1 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected at every visit during treatment and for 30 days after the end of treatment (up to 56 months for at least 1 patient). The following events were captured: Grade 1 and 2 adverse events deemed possibly, probably or definitely related to study treatment; Grade 3 and 4 adverse events regardless of attribution, and any death within 30 days of the patient's last study treatment or procedure regardless of attribution..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.
Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)
· Phase 2, PHASE3
· not yet recruiting
NCT07247097 — ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred
· Phase 2
· not yet recruiting
NCT07465029 — A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in
· active not recruiting
NCT07261163 — Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma
· Phase 2
· not yet recruiting
NCT06910124 — Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Neg
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PrECOG, LLC.
Last refreshed: 24 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00790842.