Clinical trial · Interventional
CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
A Phase II Trial of CC-4047 Plus Dexamethasone in Patients With Relapsed of Refractory Multiple Myeloma or Amyloidosis
- 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: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Relapsed Myeloma (<4 Prior Regimens)
- description
- Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
- interventionNames
- Drug: dexamethasone
- Drug: pomalidomide
- type
- EXPERIMENTAL
- label
- Lenalidomide Refractory Myeloma
- description
- Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
- interventionNames
- Drug: dexamethasone
- Drug: pomalidomide
- type
- EXPERIMENTAL
- label
- Bortezomib/Lenalidomide Refractory/Relapsed Myeloma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Symptomatic multiple myeloma
* Previously treated disease meeting one of the following criteria:
* Have light-chain amyloidosis that has been treated with at least one prior regimen
* Symptomatic (relapsed or refractory) multiple myeloma
* Patients must have received 1-3 treatment regimens
* Induction therapy followed by autologous stem cell transplantation and consolidation considered one regimen
* Measurable disease, as defined by 1 of the following:
* Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
* More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
* Serum immunoglobulin free light chain (FLC) \> 10 mg/dL and an abnormal FLC ratio
* Measurable soft tissue plasmacytoma, not previously irradiated
* More than 30% plasma cells in bone marrow
* At least 10% plasma cells as measured by bone marrow aspirate, bone marrow biopsy, or labeling index
* No monoclonal gammopathy of undetermined significance (not applicable for patients with amyloid)
* No smoldering myeloma (not applicable for patients with amyloid)
PATIENT CHARACTERISTICS:
* ECOG performance status 0, 1, or 2
* ANC ≥ 1,000/μL
* Platelet count ≥ 75,000/μL
* Creatinine ≤ 2.5 mg/dL
* Not pregnant or nursing
* Women must refrain from breastfeeding during study participation and for at least 28 days after discontinuation of study drug
* Negative pregnancy test
* Fertile female patients must use two reliable forms of contraception simultaneously at least 28 days before beginning, during, and at least 28 days after completion of study drug
* The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device \[IUD\], hormonal \[birth control pills, injections, or implants\], tubal ligation, or partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, or cervical cap)
* Fertile male patients must use a latex condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment
* Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug
* Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug
* No uncontrolled infection
* No other active malignancy
* No New York Heart Association class III or IV cardiac disease (all patients)
* Serum troponin T \> 0.10 ng/mL (amyloid patients only)
* No known positivity for HIV or active hepatitis infection
* No active deep vein thrombosis or pulmonary embolism that has not been therapeutically anticoagulated
* No condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk for participating in the study or confounds the ability to interpret data from the study
* No known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash
* No peripheral neuropathy \> grade 2
PRIOR CONCURRENT THERAPY:
* All previous cancer therapy, including chemotherapy and investigational agents, must have been discontinued ≥ 2 weeks prior to study registration
* No radiotherapy ≤ 14 days prior to study registration
* No other concurrent anti-myeloma therapy
* No concurrent radiotherapy, except for palliation of a single painful bone lesion or fracture
* Routine concurrent bisphosphonate therapy allowed for patients with myeloma bone disease
* Willing and able to take aspirin or alternate prophylactic anticoagulationReferences
Publications (2)
- DERIVEDDispenzieri A, Buadi F, Laumann K, LaPlant B, Hayman SR, Kumar SK, Dingli D, Zeldenrust SR, Mikhael JR, Hall R, Rajkumar SV, Reeder C, Fonseca R, Bergsagel PL, Stewart AK, Roy V, Witzig TE, Lust JA, Russell SJ, Gertz MA, Lacy MQ. Activity of pomalidomide in patients with immunoglobulin light-chain amyloidosis. Blood. 2012 Jun 7;119(23):5397-404. doi: 10.1182/blood-2012-02-413161. Epub 2012 Apr 4. PMID 22493299
- DERIVEDLacy MQ, Allred JB, Gertz MA, Hayman SR, Short KD, Buadi F, Dispenzieri A, Kumar S, Greipp PR, Lust JA, Russell SJ, Dingli D, Zeldenrust S, Fonseca R, Bergsagel PL, Roy V, Stewart AK, Laumann K, Mandrekar SJ, Reeder C, Rajkumar SV, Mikhael JR. Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: comparison of 2 dosing strategies in dual-refractory disease. Blood. 2011 Sep 15;118(11):2970-5. doi: 10.1182/blood-2011-04-348896. Epub 2011 Jun 20. PMID 21690557