Clinical trial · Interventional
Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia
Phase I Study of Pomalidomide, Dexamethasone and Rituximab (PDR) in Relapsed or Refractory Waldenstrom's Macroglobulinemia
NCT01078974CI-TRIAL-00023215terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Safety concerns (IgM Flare)
Summary
Brief summary (as posted)
Pomalidomide is a newly discovered drug that may stop cancer cells from growing abnormally. Pomalidomide may also stimulate the immune system to fight the cancer cells and possibly improve the effectiveness of dexamethasone and rituximab to fight the Waldenstrom's Macroglobulinemia (WM) cancer cells. This drug have been used in multiple myeloma and information from these other research studies suggests that Pomalidomide may help to reduce or prevent the growth of cancer cells.
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 |
|---|---|---|---|
| Waldenstrom's Macroglobulinemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| pomalidomide | Drug | Pomalidomide | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pomalidomide, dexamethasone, rituximab
- description
- Drug: pomalidomide Taken orally once a day Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
- interventionNames
- Drug: pomalidomide
- Drug: dexamethasone
- Drug: rituximab
Primary outcomes (2)
- measure
- Maximum Tolerated Dose of Pomalidomide
- timeFrame
- 2 years
- description
- To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.
- measure
- Tolerability of Pomalidomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Able to adhere to the study visit schedule and other protocol requirements * Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria * CD20 positive based on any previous performed bone marrow immunohistochemistry or flow cytometric analysis * Meet criteria to treat based on consensus panel criteria * Patient must have received at least one previous therapy for WM * All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study * Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of 2 times (or greater) the upper limit of each institution's normal value is required * ECOG Performance status of 0, 1 or 2 * Laboratory tests within ranges outlined in the protocol * Disease free of prior malignancies for 5 years or more with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast * Screening of patients at high risk of HBV or HCV infection * Willing and able to take aspirin or alternate prophylactic anticoagulants Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness * Pregnant or lactating females * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * Resistance or intolerance to prior rituximab therapy * Previous therapy with thalidomide or lenalidomide * Known hypersensitivity to thalidomide, lenalidomide or pomalidomide * The development of erythema nodosum if characterized by a desquamating rash while taking similar drugs * Concurrent use of other anti-cancer agents or treatments * History of non-compliance to medical regimens * Patients unwilling to or unable to comply with the protocol * Known positive for HIV or hepatitis infection * Any history of CVA (Cerebral Vascular Accident/stroke) or clots * Active DVT or PE that has not been therapeutically anticoagulated * NYHA classification III and greater heart failure * Any patient that is unable to ingest or process pomalidomide
References
Publications (0)
Data not yet available
No reference posted for this study.