Trial · NCT00602641
Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT00602641, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2015-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma. Trials, record NCT00602641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00602641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
- NCT number
- NCT00602641
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 306 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Multiple Myeloma
- Interventions
- Laboratory Biomarker Analysis, Lenalidomide, Melphalan, Prednisone, Quality-of-Life Assessment, Thalidomide
- First posted
- 2008-01-28
- Last updated
- 2026-10-01
- Results first posted
- 2015-06-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. | PFS is defined as the time from randomization to the earlier of progression or death of any cause. |
| Secondary | Overall Survival | Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. | Overall survival was defined as time from randomization to death from any cause. |
| Secondary | Very Good Partial Response (VGPR) Rate | Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry. | Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component \<100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria. |
| Secondary | Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 | Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit. | A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. | Intention-to-treat (ITT) population | months | MEDIAN |
| SECONDARY | Overall Survival | Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. | Intention-to-treatment (ITT) population | months | MEDIAN |
| SECONDARY | Very Good Partial Response (VGPR) Rate | Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry. | Intention-to-treat (ITT) population | proportion of participants | NUMBER |
| SECONDARY | Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 | Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit. | Patients who completed both baseline and cycle 12 QOL assessments. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Arm I (MPT-T) | 21.0 | 95% Confidence Interval 18.2 to 27.5 | months | |
| Progression-Free Survival (PFS) | Arm II (mPR-R) | 18.7 | 95% Confidence Interval 16.0 to 22.1 | months | |
| Overall Survival | Arm I (MPT-T) | 52.6 | 95% Confidence Interval 40.4 to NA | months | |
| Overall Survival | Arm II (mPR-R) | 47.7 | 95% Confidence Interval 41.0 to 56.4 | months | |
| Very Good Partial Response (VGPR) Rate | Arm I (MPT-T) | 0.247 | 95% Confidence Interval 0.179 to 0.315 | proportion of participants | |
| Very Good Partial Response (VGPR) Rate | Arm II (mPR-R) | 0.316 | 95% Confidence Interval 0.242 to 0.390 | proportion of participants | |
| Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 | Arm I (MPT-T) | -2.8 | Standard Deviation 15.0 | units on a scale | |
| Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 | Arm II (mPR-R) | 3.3 | Standard Deviation 13.7 | units on a scale |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (MPT-T) | 154 | |
| Overall Study | STARTED | Arm II (mPR-R) | 152 | |
| Overall Study | Started Protocol Therapy | Arm I (MPT-T) | 148 | |
| Overall Study | Started Protocol Therapy | Arm II (mPR-R) | 150 | |
| Overall Study | COMPLETED | Arm I (MPT-T) | 0 | |
| Overall Study | COMPLETED | Arm II (mPR-R) | 0 | |
| Overall Study | NOT COMPLETED | Arm I (MPT-T) | 154 | |
| Overall Study | NOT COMPLETED | Arm II (mPR-R) | 152 |
Source ClinicalTrials.gov
Adverse events230
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | MPT-T | 11 | 148 | |
| other | Anemia | Blood and lymphatic system disorders | mPR-R | 22 | 151 | |
| other | White blood cell decreased | Investigations | MPT-T | 12 | 148 | |
| other | White blood cell decreased | Investigations | mPR-R | 17 | 151 | |
| other | Lymphocyte count decreased | Investigations | MPT-T | 10 | 148 | |
| other | Lymphocyte count decreased | Investigations | mPR-R | 9 | 151 | |
| other | Neutrophil count decreased | Investigations | MPT-T | 8 | 148 | |
| other | Neutrophil count decreased | Investigations | mPR-R | 12 | 151 | |
| other | Platelet count decreased | Investigations | MPT-T | 10 | 148 | |
| other | Platelet count decreased | Investigations | mPR-R | 17 | 151 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MPT-T | ||
| Total, all-cause mortality | mPR-R | ||
| Total, other adverse events | MPT-T | 29 | 148 |
| Total, other adverse events | mPR-R | 34 | 151 |
| Total, serious adverse events | MPT-T | 110 | 148 |
| Total, serious adverse events | mPR-R | 88 | 150 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26157076 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MPT-T vs mPR-R: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00602641
GET https://conductscience.org/api/trials/v1/NCT00602641/events?page=2