Clinical trial · Interventional
Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
Randomized Phase II Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden in High Risk Patients With Multiple Myeloma or Amyloidosis
NCT00651937CI-TRIAL-00042761completedPhase 2Results postedClinicalTrials.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 goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure.
Conditions
Conditions (2)
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 |
| Primary Amyloidosis | Primary Amyloidosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apheresis | Procedure | — | UNRESOLVED |
| Granulocyte-colony stimulating factor (G-CSF) | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Stem Cell Infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Dose
- description
- Melphalan + Stem Cell Infusion (Standard Dose): Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10\^6 cluster of differentiation 34 (CD34)/kg on Day 0. Melphalan 100 mg/m\^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
- interventionNames
- Drug: Melphalan
- Procedure: Stem Cell Infusion
- Behavioral: Questionnaires
- Drug: Granulocyte-colony stimulating factor (G-CSF)
- Procedure: Apheresis
- type
- ACTIVE_COMPARATOR
- label
- High Dose
- description
- Melphalan + Stem Cell Infusion (High Dose): High Dose (Arm 2) = Stem cell dose of between 10-15 x 10\^6 CD34/kg On Day 0. Melphalan 100 mg/m\^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with multiple myeloma over the age of 60 in any of the following disease categories: a) Primary refractory disease b) Consolidation of a first partial or complete remission. OR 2. Patients with primary amyloidosis. 3. Zubrod PS of \<2 or Karnofsky \>/= 70. 4. Left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease. 5. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) \>/= 40%. No symptomatic pulmonary disease. 6. Serum bilirubin \</= 2 X upper limit of normal, serum glutamate pyruvate transaminase (SGPT) \</= 4 X upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites \>1L prior to drainage. 7. HIV-negative. 8. Patient is not pregnant. 9. Patient or guardian able to sign informed consent. 10. Have greater than or equal to 10 x 10 e 6 CD34+ cells per kg of autologous stem cells cryopreserved for stem cell transplantation, procured with 5 or fewer apheresis collections. Exclusion Criteria: 1\) Patients unable to perform MDASI assessments due to language or cultural barriers.
References
Publications (0)
Data not yet available
No reference posted for this study.