Clinical trial · Interventional
Bortezomib, Doxorubicin Hydrochloride Liposome, and Dexamethasone Followed by Thalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Multiple Myeloma
Bortezomib + Pegylated Liposomal Doxorubicin (Doxil) + Dexamethasone Followed by Thalidomide + Dexamethasone or Bortezomib + Thalidomide + Dexamethasone for Patients With Symptomatic Untreated High-Risk or Primary Resistant 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: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide, dexamethasone, and bortezomib may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with doxorubicin hydrochloride liposome and dexamethasone followed by thalidomide and dexamethasone with or without bortezomib works 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination therapy
- description
- Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
- interventionNames
- Drug: bortezomib
- Drug: dexamethasone
- Drug: pegylated liposomal doxorubicin hydrochloride
- Drug: thalidomide
Primary outcomes (1)
- measure
- Disease Response
- timeFrame
- 2 years
- description
- The response of myeloma to BDDTD will be assessed by standard electrophoretic and immunofixation tests of blood and urine for a monoclonal protein (M protein), and bone marrow aspirate and biopsy. These tests will be performed at enrollment and at the conclusion of therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically and serologically confirmed multiple myeloma meeting one of the following criteria: * High-risk myeloma, defined as symptomatic International Staging System (ISS) stage 2 or 3 multiple myeloma * Soft-tissue involvement with myeloma in the form of a soft-tissue plasmacytoma * Extension of a plasmacytoma into soft tissues * Primary resistant myeloma, defined as unchanged or progressive myeloma despite two courses of standard treatment * No ISS stage 1 multiple myeloma without soft-tissue involvement * No smoldering myeloma PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Life expectancy \> 16 weeks * Absolute granulocyte count ≥ 1,500/mm³ (unless low granulocyte counts are due to multiple myeloma) * Platelet count ≥ 100,000/mm³ (unless low platelet counts are due to multiple myeloma) * Bilirubin ≤ 2.0 mg/dL * AST and ALT \< 3 times upper limit of normal (ULN) * Alkaline phosphatase \< 3 times ULN * LVEF ≥ 50% by MUGA or ECHO * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception 4 months prior to, during, and for 4 weeks after completion of study treatment * No active thromboembolic disease on anticoagulation * No active angina or myocardial infarction within the past 6 months * No pre-existing neuropathy or sensory or neuropathic pain ≥ grade 2 * No concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix * Prior malignancies that have not required antitumor treatment within the past 24 months allowed * Patients with a history of stage I or II (T1a/b) prostate cancer (detected incidentally at transurethral resection of prostate \[TURP\] and comprising \< 5% of resected tissue) allowed if the prostate-specific antigen has remained normal since TURP * No known HIV positivity or AIDS-related illness * No other medical condition or reason that, in the opinion of the investigator, would preclude study compliance * No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or to components of pegylated doxorubicin hydrochloride liposome, bortezomib, boron, or mannitol PRIOR CONCURRENT THERAPY: * Prior radiotherapy allowed * No more than 2 courses of prior initial chemotherapy for multiple myeloma * No prior bortezomib * No prior high-dose steroids (not including taper) for more than 1 month in duration for emergent indications, such as hypercalcemia or life-threatening lesions (e.g., spinal cord compromise) (in high-risk patients)
References
Publications (1)
- RESULTLandau H, Pandit-Taskar N, Hassoun H, Cohen A, Lesokhin A, Lendvai N, Drullinsky P, Schulman P, Jhanwar S, Hoover E, Bello C, Riedel E, Nimer SD, Comenzo RL. Bortezomib, liposomal doxorubicin and dexamethasone followed by thalidomide and dexamethasone is an effective treatment for patients with newly diagnosed multiple myeloma with Internatinal Staging System stage II or III, or extramedullary disease. Leuk Lymphoma. 2012 Feb;53(2):275-81. doi: 10.3109/10428194.2011.606943. Epub 2011 Sep 23. PMID 21824051