Clinical trial · Interventional
Study of Bendamustine, Lenalidomide and Low-dose Dexamethasone, for the Treatment of Patients With Relapsed Myeloma
A Phase I/II Study of Bendamustine, Lenalidomide and Low-dose Dexamethasone, (BdL) for the Treatment of Patients With Relapsed 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)
This is an open Label, Phase I/II, multicenter study. In the first phase it defines the maximum tolerated dose (MTD) of Bendamustine (B) given in combination with Lenalidomide (L) and low-dose Dexamethasone (d) and in the second phase it evaluates the antitumour activity of Bendamustine, Lenalidomide and Low-dose Dexamethasone (BdL) given in combination, in relapsed multiple myeloma patients.
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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation benda lena dexa
- description
- Phase I: Participants will be treated in groups (cohorts) of three to six subjects per cohort, according to a modified Fibonacci design. The dose of Bendamustine and Lenalidomide (from 0 to 5) will be increased from one cohort to the next. Regardless of the treatment cohort, participants will receive treatment in cycles lasting 28 days. In the first phase of the study, the dose of B and L given with will be gradually escalated to reach the MTD. Phase II: Dexamethasone will be given in combination with the MTD of Bendamustine and Lenalidomide in cycles lasting 28 days.
- interventionNames
- Drug: Bendamustine
- Drug: Lenalidomide
- Drug: Dexamethasone
Primary outcomes (3)
- measure
- Phase I:Determination of Maximum Tolerated Dose
- timeFrame
- up to 28 days during first cycle
- description
- In the first phase of the study, the dose of Bendamustine and Lenalidomide given with will be gradually escalated to reach the Maximum Tolerated Dose. The Maximum Tolerated Dose of Bendamustine and Lenalidomide will be evaluated during the first course (cycle 1) of Bendamustine Dexamethasone Lenalidomide (BdL) administered
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary written informed consent * Men and women age ≥ 18 years * Female subjects are either post-menopausal or surgically sterilized or willing to use 2 simultaneous methods of contraception * Male patients must agree to use a latex condom during sexual contact with females of childbearing potential throughout the study and for at least 28 days following discontinuation of lenalidomide; * Confirmed diagnosis of Multiple Myeloma with measurable disease .Patients with evidence of relapsed disease after more than 1 and equal but not more than 3 prior lines of therapy. * ECOG Performance Status 0 - 2 * Required baseline haematology and chemistry parameters Exclusion Criteria: * Myocardial infarction within 6 months prior to enrollment or has NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. * Female subjects either pregnant or breast-feeding (negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result) * Patients have received other investigational drugs with 14 days before enrollment. * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) \<1,000 /μl (1x109 /L) Untransfused platelet count \< 50,0000cell/μl (50x109 /L) Serum SGOT/AST or SGPT/ALT \> 2.0 upper limit of normal (ULN) Total bilirubin \> 2.0 mg/dL Renal insufficiently (serum creatinine level \> 2.5 mg/dl or Creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault estimation) * Patients with active infections are ineligible. * Patients who are HIV positive are ineligible. * Patients with active leptomeningeal involvement are ineligible. * Patients with a history of previous CSF tumor involvement without symptoms or signs are eligible provided the CSF is now free of disease on lumbar puncture, and MRI of the brain shows no tumor involvement. * History of other malignancies within 3 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or breast, low grade, early stage localized prostate cancer treated surgically with curative intent (TNM stage of T1a or T1b), * Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal dysfunction are ineligible. * Patients with an ECOG performance status of \> 2 are ineligible. * Malabsorption syndrome or uncontrolled gastrointestinal toxicities * Clinically significant pleural effusion in the previous 12 months or current ascitis * Clinically-significant coagulation or platelet function disorder * Intolerance to bendamustine and/or lenalidomide
References
Publications (25)
- BACKGROUNDMunshi NC, Tricot G, Barlogie B. Plasma cell neoplasms. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: principles and practice of oncology, 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2001:2465-99.
- BACKGROUNDJemal A, Thomas A, Murray T, Thun M. Cancer statistics, 2002. CA Cancer J Clin. 2002 Jan-Feb;52(1):23-47. doi: 10.3322/canjclin.52.1.23. PMID 11814064
- BACKGROUNDDurie BG. The epidemiology of multiple myeloma. Semin Hematol. 2001 Apr;38(2 Suppl 3):1-5. doi: 10.1016/s0037-1963(01)90087-3. PMID 11309701
- BACKGROUNDKishi Y, Oki Y, Machida U. Thalidomide in multiple myeloma. N Engl J Med. 2000 Mar 30;342(13):975; author reply 975-6. doi: 10.1056/NEJM200003303421313. No abstract available. PMID 10744492
- BACKGROUNDWeber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596. PMID 18032763
- BACKGROUNDDimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594. PMID 18032762
- BACKGROUNDPalumbo A, Falco P, Corradini P, Falcone A, Di Raimondo F, Giuliani N, Crippa C, Ciccone G, Omede P, Ambrosini MT, Gay F, Bringhen S, Musto P, Foa R, Knight R, Zeldis JB, Boccadoro M, Petrucci MT; GIMEMA--Italian Multiple Myeloma Network. Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA--Italian Multiple Myeloma Network. J Clin Oncol. 2007 Oct 1;25(28):4459-65. doi: 10.1200/JCO.2007.12.3463. Epub 2007 Sep 4.