Clinical trial · Interventional
Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Phase I/II Trial of Melphalan, Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant
NCT00477750CI-TRIAL-00041108completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Lenalidomide, Melphalan, Prednisone)
- description
- Intervention: Drug: lenalidomide Dose determined by Phase I treatment schedule. Taken orally days 1-21 every 28 days until progression Intervention: Drug: melphalan Dose determined by Phase I treatment schedule. Taken orally days 1-4 every 28 days until progression Intervention: Drug: prednisone 60mg/m\^2, orally days 1-4 every 28 days until progression
- interventionNames
- Drug: lenalidomide
- Drug: melphalan
- Drug: prednisone
Primary outcomes (1)
- measure
- Patients With Overall Confirmed Response
- timeFrame
- Every cycle during treatment
- description
- Response that was confirmed on 2 consecutive evaluations.\> * Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and \<=5% plasma cells in bone marrow\> * Very Good Partial Response (VGPR): \>=90% reduction in serum M-spike, Urine M-spike \<100mg per 24 hours\> * Partial Response (PR): \>=50% reduction in serum M-spike, Urine M-spike \>=90% reduction or \< 200mg per 24 hours, or \>=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma
* Newly diagnosed disease
* Requires treatment, in the judgment of the treating physician
* Not a candidate for (or patient declines) autologous stem cell transplantation
* Meets 1 of the following criteria:
* Measurable disease, defined by any of the following:
* Serum monoclonal protein ≥ 1 g/dL
* Urine protein monoclonal light chain ≥ 200 mg/24 hours by electrophoresis
* Measurable serum free light chains ≥ 10 mg/dL, kappa or lambda, AND κ/λ ratio is abnormal (if serum and urine are not measurable as defined above)
* Evaluable disease, defined as monoclonal bone marrow plasmacytosis ≥ 30%
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm³
* Bilirubin ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
* AST ≤ 3 times ULN
* Creatinine ≤ 3.0 mg/dL
* Platelet count ≥ 100,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception, including ≥ 1 highly effective method, ≥ 4 weeks before and during study treatment
* No uncontrolled infection
* No peripheral neuropathy ≥ grade 2
* No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance
* No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ
\- Prior malignancy allowed if treated with curative intent and is free of disease for a period appropriate for that cancer
* No known hypersensitivity to thalidomide
* No known HIV positivity
* No infectious hepatitis A, B or C
* No history of deep vein thrombosis or other medical condition requiring the use of warfarin
* Able to take daily prophylactic acetylsalicylic acid (81 or 325 mg)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy for treatment of multiple myeloma
* No prior lenalidomide
* No other concurrent anticancer agents or treatments
* No concurrent steroids except prednisone ≤ 20 mg/day (or the equivalent) for concurrent illness or adrenal replacement therapy
* No other concurrent investigational therapy or agent for treatment of multiple myeloma
* No concurrent warfarinReferences
Publications (0)
Data not yet available
No reference posted for this study.