Clinical trial · Interventional
Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma
A Randomized Phase II Dose Finding Study of Revlimid™ and Melphalan in Patients With Previously Untreated Multiple Myeloma
- 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: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, 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 melphalan may kill more cancer cells. PURPOSE: This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with 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 |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| lenalidomide | Drug | Lenalidomide | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of dose-limiting toxicity within first 3 courses of treatment
Secondary outcomes (7)
- measure
- Toxicity
- measure
- Disease response after 2 courses, 6 courses, 12 courses, and 6 months of maintenance therapy
- measure
- Time to progression
- measure
- Overall survival
- measure
- Duration of disease-free interval
- measure
- Time to dose modification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed multiple myeloma by one of the following:
* Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
* Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis
* Bone marrow \< 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein criteria
* Ineligible for stem cell transplantation due to any of the following:
* Advanced age
* Comorbid illness
* Patient preference
* Previously untreated disease
* Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis
* No nonsecretory myeloma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 months
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 150,000/mm\^3
* Creatinine ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* AST and/or ALT ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 methods of effective contraception during and for 4 weeks after completion of study treatment
* No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancer of the cervix
* No hypersensitivity to thalidomide or its components, including the development of a desquamating rash
* No other serious illness or medical condition that would preclude study participation
* No history of significant neurologic or psychiatric disorder that would preclude informed consent
* No known HIV positivity
* No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following:
* Significant cardiac event (including symptomatic heart failure or angina) within 3 months prior to randomization
* Any cardiac disease that increases risk for ventricular arrhythmia
* History of ventricular arrhythmia that was symptomatic or required treatment, including any of the following:
* Multifocal premature ventricular contractions
* Bigeminy
* Trigeminy
* Ventricular tachycardia/fibrillation/flutter/arrhythmia NOS
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or corticosteroids for the treatment of multiple myeloma
* Prior corticosteroids for the treatment of hypercalcemia or spinal cord compression allowed provided maximum levels have not been reached (i.e.,\< 120 mg for dexamethasone or \< 792 mg for prednisone)
* Prior radiotherapy to single sites for pain control or local plasmacytoma allowed
* Prior or concurrent bisphosphonates allowed
* At least 28 days since prior investigational anticancer agents or therapy
* No concurrent corticosteroids above physiologic replacement doses
* Concurrent radiotherapy to sites of active myeloma with pain or neurologic compromise allowed
* No concurrent filgrastim (G-CSF) on day 1 of course 1
* No other concurrent anticancer therapy
* No other concurrent investigational therapyReferences
Publications (4)
- BACKGROUNDWhite DJ, Paul N, Macdonald DA, Meyer RM, Shepherd LE. Addition of lenalidomide to melphalan in the treatment of newly diagnosed multiple myeloma: the National Cancer Institute of Canada Clinical Trials Group MY.11 trial. Curr Oncol. 2007 Apr;14(2):61-5. doi: 10.3747/co.2007.107. PMID 17576467
- RESULTWhite DJ, Bahlis NJ, Marcellus DC, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: the NCIC CTG MY.11 trial. [Abstract] Blood 112 (11): A-2767, 2008.
- RESULTWhite DJ, Kovacs MJ, Belch A, et al.: Phase II testing of lenalidomide plus melphalan for previously untreated older patients with multiple myeloma: toxicity data from the NCIC CTG MY.11 trial. [Abstract] Blood 110 (11): A-189, 2007.
- DERIVEDWhite DJ, Bahlis NJ, Marcellus DC, Belch A, Stewart AK, Chen C, Kovacs MJ, Macdonald DA, Reece DE, Reiman T, Harnett E, Meyer RM, Chapman JA, Couban S. Lenalidomide plus melphalan without prednisone for previously untreated older patients with multiple myeloma: a phase II trial. Clin Lymphoma Myeloma Leuk. 2013 Feb;13(1):19-24. doi: 10.1016/j.clml.2012.08.009. Epub 2012 Nov 7. PMID 23141150