Clinical trial · Interventional
Safety and Dose Study of GRN163L Administered to Treat Patients With Refractory or Relapsed Multiple Myeloma
A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma
NCT00594126CI-TRIAL-00020321completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed 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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imetelstat Sodium (GRN163L) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- 3+3 cohort dose escalation
- interventionNames
- Drug: Imetelstat Sodium (GRN163L)
Primary outcomes (1)
- measure
- Safety and MTD
- timeFrame
- First 3 weeks
Secondary outcomes (1)
- measure
- PK, PD, and efficacy
- timeFrame
- Baseline to end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease) * Relapsed or refractory disease * At least two prior treatment regimens * ECOG performance status 0-2 * Adequate hepatic/renal function and platelet count * If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50% Exclusion Criteria: * Prior allogeneic bone marrow transplant, including syngeneic transplant * Known intracranial disease or epidural disease * Prior malignancy (within the last 3 years) * Clinically significant cardiovascular disease or condition * Active or chronically recurrent bleeding (eg, active peptic ulcer disease * Prolongation of PT or aPTT \> the ULN or fibrinogen \< the LLN * Clinically relevant active infection * Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease * Symptomatic hyperviscosity syndrome * Any other cancer therapy within 3 weeks prior to study, except for mitomycin C, nitrosoureas, or high-dose chemotherapy with stem cell support within 6 weeks prior to study * Investigational therapy within 4 weeks prior to study * Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices * Radiation therapy within 4 weeks prior to study * Major surgery within 4 weeks prior to study * Active autoimmune disease requiring immunosuppressive therapy * Known positive serology for HIV
References
Publications (0)
Data not yet available
No reference posted for this study.